The Recall Desk

FDA (Devices) recall action 63467

Biomerieux Inc recalled 31 products on 2012-11-28

The FDA (Devices) publishes a recall like this one as 31 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 31 pages.

Products
31
Announced
2012-11-28
Critical
0
Units
6,400

Why these products were recalled

The product may mislabel patient information on culture specimen bottles due to a software miscommunication.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 31

  • ModerateFDA (Devices)··2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 30 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that ar
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux BacT/ALERT Combo Module Recalled for Software Miscommunication

    BioMerieux is recalling 26 BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux BTA3D Combo Software Recall for Patient Mislabeling

    BioMerieux is recalling 205 BTA3D Combo software kits worldwide due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediat
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 671 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens dra
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMérieux 3D IND Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pati
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling

    BioMerieux is recalling 375 BacT/ALERT Combo Modules due to a software error that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, w
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMérieux BacT/ALERT 3D 60 Recalled for Software Mislabeling Error

    BioMérieux is recalling 145 BacT/ALERT 3D 60 modules worldwide because a software error may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which ca
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux B.40 Dualt-ML Software Update Recalled for Mislabeling Risk

    BioMerieux is recalling B.40 Dualt-ML software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover speci
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMérieux Software Update Recalled for Patient Information Mislabeling

    BioMérieux is recalling 205 software update kits for clinical instruments due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    Biomerieux B.40 Software Update Recalled for Patient Information Mislabeling

    Biomerieux Inc is recalling 33 B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 23 B.40 software update kits because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 860 units of 3D B.40 software updates due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 620 units of 3D B.40 software updates because a software error may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 1,336 units of 3D B.40 software due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux BacT/ALERT Control Module Recalled for Software Mislabeling

    BioMerieux is recalling BacT/ALERT Control Modules because a software issue may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    Biomerieux BacT/ALERT Combo Module Recalled for Software Mislabeling

    Biomerieux is recalling BacT/ALERT Combo Modules due to a software issue that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    Biomerieux B.40 Software Update Recalled for Patient Mislabeling

    Biomerieux Inc is recalling 22 B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients t
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMérieux BTA3D Control Software Recall for Patient Mislabeling

    BioMérieux is recalling BTA3D Control software due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pedi
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    bioMerieux BacT/ALERT Control Module Recalled for Patient Mislabeling

    Biomerieux Inc is recalling 70 BacT/ALERT Control Modules due to a software issue that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection,
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Mislabeling Patient Information

    BioMerieux is recalling 556 units of 3D B.40 software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric pa
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling a software update for the 3D B.40 clinical instrument because it may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 163 units of the 3D B.40 software update because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
    Category
    Distribution
    19 states