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
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…
Category
Distribution
19 states
ModerateFDA (Devices)··2012-11-28
BioMerieux 3D B.40 Software Update Recalled for Mislabeling Risk
BioMerieux is recalling 28 software updates for the 3D B.40 instrument due to a defect that may mislabel patient information on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 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
BioMerieux 3D IND ZIP-ML Software Update Recalled for Mislabeling
BioMerieux is recalling 288 units of the 3D IND ZIP-ML software update because a defect may cause patient information to be mislabeled on culture specimen bottles.
Product
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 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 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…
Category
Distribution
19 states
ModerateFDA (Devices)··2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 250 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-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 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 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…
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 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…
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…
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…
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 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 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 12 kits 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-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 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
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…
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…
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…
Category
Distribution
19 states
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…
Category
Distribution
19 states
ModerateFDA (Devices)··2012-11-28
BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 69 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 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinical instrument which is most commonly used to isolate and recover specimens…
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 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…
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…
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 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…
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 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…
Category
Distribution
19 states