Bio-Rad Laboratories, Inc recalls MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with o…

Recall date

June 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1742-2019

FDA classification

Class II

Brand / firm

Bio-Rad Laboratories, Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.