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U.S. Department of Health and Human Services

Class 2 Device Recall MRSASelect

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  Class 2 Device Recall MRSASelect see related information
Date Initiated by Firm June 08, 2018
Create Date June 06, 2019
Recall Status1 Terminated 3 on October 30, 2020
Recall Number Z-1742-2019
Recall Event ID 82761
510(K)Number K081212  
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact Ms. Tina Cuccia
510-741-6063
Manufacturer Reason
for Recall		 Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 5,212 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JSO and Original Applicant = BIO-RAD
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