FDAClass IIJune 12, 2019

MRSASelect II recall

MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical…

Why was MRSASelect II recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical…
Recalling firm
Bio-Rad Laboratories, Inc
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.
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls