Roche recalls certain MRSA/SA test kits due to potential reduced accuracy, risking missed infections. The US is unaffected as these tests aren't available here.
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. 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.
Roche is recalling specific MRSA/SA test kits that may not work as intended, which could lead to undetected infections in patients and spread of MRSA. The US is not affected because these tests aren't available in the country.
The tests might not detect MRSA accurately, meaning infections could go unnoticed in patients and potentially spread to others. The US isn't impacted because these tests aren't available here.
People who purchased or use the recalled MRSA/SA test kits for in vitro diagnostics. Those with the specific lot numbers are most at risk.
Check the lot numbers: 70712A (6 kits), 70601W (76 kits), 70713A (4 kits), 70718A (50 kits). These kits were sold for in vitro diagnostic use.
Look for lot numbers 70712A, 70601W, 70713A, or 70718A on the test kits.
No, 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 recall record does not specify a remedy, so no action is required beyond checking the lot numbers.
Check the lot numbers: 70712A (6 kits), 70601W (76 kits), 70713A (4 kits), and 70718A (50 kits).
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1195-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1195-2018 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
