The Recall Desk

FDA (Devices) recall action 82761

Bio-Rad Laboratories, Inc recalled 2 products on 2019-06-12

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-06-12
Critical
0
Units
8,844

Why these products were recalled

Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

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

1–2 of 2

  • ModerateFDA (Devices)··2019-06-12

    Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.

    Product
    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2019-06-12

    Bio-Rad Recalls MRSASelect II Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling MRSASelect II diagnostic plates due to abnormal agar coloration and non-characteristic colony growth. The recall covers 3,632 units distributed nationwide.

    Product
    MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Distribution
    49 states