Recall Z-1743-2019

Bio-Rad Laboratories, Inc · initiated June 8, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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.

Codes / lots: Lot numbers 64177778, exp. 6/10/2018; 64179165, exp. 6/17/2018; 64182547, exp. 7/3/2018; 64184389, exp. 7/8/2018; 64187554, exp. 7/22/2018; 64189124, exp. 7/23/2018; and 64190805, exp. 7/31/2018.

Reason for recall

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

FDA-determined cause: Nonconforming Material/Component

Action taken

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 recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or PASTOREX STAPH-PLUS. Please feel free to contact Technical Support with any questions or concerns at 1-800-224-6723, option #2 and then #3.

Details

Recall number
Z-1743-2019
Initiated
June 8, 2018
Terminated
October 30, 2020
Product code
JSO – Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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.
Recalling firm
Bio-Rad Laboratories, Inc, Redmond, WA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1742-2019 Class IIMRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is…Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. 06/08/2018Terminated