Roche Recalls cobas MRSA/SA Nucleic Acid Tests for Decreased Performance
Roche Molecular Systems is recalling cobas MRSA/SA tests worldwide due to decreased performance that may lead to screening failures and potential infection spread.
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 involves a risk-of-harm product (infection spread) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 136 kits of the cobas MRSA/SA nucleic acid test intended for screening for MRSA/SA. Each kit contains 20 tubes. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because the tests may have decreased performance compared to the analytical sensitivity for MRSA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MRSA to others.
The affected lots are 70712A (6 kits), 70601W (76 kits), 70713A (4 kits), 70718A (50 kits), and 70809A (kits were not distributed to end users). The product was distributed worldwide to Austria, Denmark, Germany, Singapore, the Netherlands, Hong Kong, and Switzerland. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
The recalled product
- Product
- Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 136
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 (5)
- Lot #s: 70712A (6 kits)
- 70601W (76 kits)
- 70713A (4 kits)
- 70718A (50 kits)
- and 70809A (kits were not distributed to end users).
Distribution
Distribution scope not specified by the agency.
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