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.
Reported: June 12, 2019 Initiated: June 8, 2018 #Z-1743-2019
Product Description
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.
Reason for Recall
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Details
- Recalling Firm
- Bio-Rad Laboratories, Inc
- Units Affected
- 3,632 units
- Distribution
- US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bio-Rad Laboratories, Inc. Units affected: 3,632 units.
Why was this product recalled? ▼
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1743-2019.
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