Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration
Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling 5,212 units of MRSASelect, In Vitro Diagnostic (IVD), REF 63747. The product consists of 20 plates per package and is indicated for use in conjunction with other laboratory tests and clinical data to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
The recall was initiated due to abnormal coloration of the agar plates and the growth of non-characteristic MRSA colonies. The affected units are distributed nationwide to all 50 states, the District of Columbia, and Puerto Rico.
The specific lot numbers subject to recall are 64179161 (exp. 6/8/2018), 64180987 (exp. 6/15/2018), 64182474 (exp. 6/23/2018), 64184888 (exp. 6/30/2018), 64187551 (exp. 7/6/2018), 64189117 (exp. 7/13/2018), 64190797 (exp. 7/22/2018), and 64192125 (exp. 8/3/2018). Healthcare facilities and laboratories should discontinue use of these specific lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Bio-Rad Laboratories, Inc
- Affected units
- 5,212
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lot numbers 64179161
- exp. 6/8/2018
- 64180987
- exp. 6/15/2018
- 64182474
- exp. 6/23/2018
- 64184888
- exp. 6/30/2018
- 64187551
- exp. 7/6/2018
- 64189117
- exp. 7/13/2018
- 64190797
- exp. 7/22/2018
- and 64192125
- exp. 8/3/2018.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bio-Rad Laboratories, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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