Cepheid recalls Xpert Xpress Strep A tests with potential for invalid results due to pipette issues. Affected units include specific lot numbers and model.
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Cepheid is recalling Xpert Xpress Strep A tests that may not dispense enough sample volume, leading to invalid or no results. This could cause inaccurate strep throat testing.
The pipettes in the test kit may not dispense an adequate sample volume, causing the test to show invalid results or no result. This could lead to incorrect diagnosis of strep throat.
Users of the Xpert Xpress Strep A test kit, particularly those testing for strep throat. People who rely on accurate test results for diagnosis are most at risk.
Check the product label for the model 'Xpert Xpress Strep A' and lot number 23815. The unique device identifier (UDI) starts with (01)07332940006297.
Look for the model 'Xpert Xpress Strep A' and lot number 23815 on the test kit.
The pipettes in the test kit may fail to dispense an adequate sample volume, leading to invalid or no results.
Check the product label for the model and lot number. If it matches, contact Cepheid for instructions.
The recall is for potential invalid test results, not a physical hazard. There is no risk of injury.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0216-2024 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0216-2024 from Cepheid. 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.
