FDAFDA · Food and drugs·Recall number Z-1742-2019
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.
Published June 12, 2019 · Recall initiated: June 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-Rad Laboratories, Inc
- Distributor
- 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.
- Lot
- Lot numbers 64179161, exp. 6/8/2018; 64180987, exp. 6/15/2018; 64182474, exp. 6/23/2018; 64184888, exp. 6/30/2018; 64187551, exp. 7/6/2018; 64189117, exp. 7/13/2018; 64190797, exp. 7/22/2018; and 64192125, exp. 8/3/2018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.