Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1743-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-06-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1743-2019
Date of alert: 2018-06-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bio-Rad Laboratories, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 64177778

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1743-2019 — 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.

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