Bio-Rad Laboratories, Inc: Medical Device Recall in 2019 - (Recall #: Z-1743-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 8, 2018

Date Posted: June 12, 2019

Recall Number: Z-1743-2019

Event ID: 82761

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,632 units

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated