Recall Z-1742-2019— Bio-Rad Laboratories, Inc
Class II · Terminated
Class II FDA medical device recall by Bio-Rad Laboratories, Inc, initiated 2018-06-08, terminated 2020-10-30. It names one FDA 510(k) clearance: K081212. 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: Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies..
- Recalling firm
- Bio-Rad Laboratories, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-08
- Terminated
- 2020-10-30
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.