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

    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 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 pe
    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 draw
    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 pati
    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