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High RiskFDAfda-Z-1743-2019OTHER

MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests...

Units Affected
3,632
Recall Date
June 8, 2018
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1743-2019.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1743-2019.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1743-2019.

Bio-Rad Laboratories, Inc

FDA

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Bio-rad Laboratories, Inc Recall FAQ

Bio-rad Laboratories, Inc is the subject of a medical devices safety report: MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests.... The notice was published on June 8, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 3,632 units are potentially affected.