The Recall Desk
HighFDA (Devices)·Z-1743-2019·Announced 2019-06-12

Bio-Rad Recalls MRSASelect II Diagnostic Plates Due to Abnormal Coloration

Bio-Rad Laboratories is recalling MRSASelect II diagnostic plates due to abnormal agar coloration and non-characteristic colony growth. The recall covers 3,632 units distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a diagnostic device for a high-risk pathogen (MRSA) where the defect could lead to misdiagnosis, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Bio-Rad Laboratories, Inc. is recalling MRSASelect II, IVD, REF 63758 (20 plates per package). The product 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 involves 3,632 units.

The recall was initiated due to abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. The affected lot numbers are 64177778, 64179165, 64182547, 64184389, 64187554, 64189124, and 64190805, with expiration dates ranging from June 10, 2018, to July 31, 2018.

The products were distributed nationwide to all 50 states, the District of Columbia, and Puerto Rico. Users should stop using the affected products and contact Bio-Rad Laboratories for further instructions.

The recalled product

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.
Manufacturer
Bio-Rad Laboratories, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
3,632

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 (14)

  • 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

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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.

See all 2 products in this recall →

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