Recall Z-1743-2019 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Bio-Rad Laboratories, Inc
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.
| Date | Jun 8, 2018 |
| Status | Terminated |
| Reason | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. |
| Root cause | Nonconforming Material/Component |
| Action | The firm. Bio-Rad laboratories, Inc., issued an "URGENT PRODUCT CORRECTION" letter dated 6/7/2018 to all customers via FedEx on 6/7-8/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " As already recommended in the package insert, please ensure that exposure of agar plates to light is minimized, both before and during incubation, with the added time restriction of no more than 2 hours during storage, warming, incubation, and reading. " Do not use agar with a change in color from white to an orange-pinkish shade. " As re |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171061 | MRSASelect II Bio-Rad, Dec 28, 2017 |