Data Foundry

Medical device recalls 2019

MRSASelect — Class II medical device recall Z-1742-2019

Terminated recall by Bio-Rad Laboratories, Inc, reported 2019-06-12, distributed nationwide. Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

Recall numberZ-1742-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBio-Rad Laboratories, Inc, Redmond, WA, United States
Recall initiated2018-06-08
Classified2019-06-06
Reported by FDA2019-06-12
Terminated2020-10-30
DistributedNationwide (US)
Quantity5,212 units
Lot numbers64179161, 64180987, 64182474, 64184888, 64187551, 64189117, 64190797, 64192125
Model numbers63747
Expiration dates2018-06-08, 2018-06-15, 2018-06-23, 2018-06-30, 2018-07-06, 2018-07-13, 2018-07-22, 2018-08-03

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1742-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.