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

26–31 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 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…
    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…
    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…
    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…
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2012-11-28

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

    BioMérieux is recalling 29 units of the 3D B.40 USB-ML03 software update due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 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

    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…
    Category
    Distribution
    19 states