FDA Device recall Z-1743-2019
MRSASelect II, IVD, REF 63758 (20 plates per package)
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of MRSASelect II, IVD, REF 63758 (20 plates per package) by Bio Rad Laboratories, citing abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1743-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-08 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
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.
Reason
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Identifiers
| code_info | Lot numbers 64177778, exp. 6/10/2018; 64179165, exp. 6/17/2018; 64182547, exp. 7/3/2018; 64184389, exp. 7/8/2018; 6418…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1743-2019%22
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