BioMérieux recalls VIDAS LH tests with reference numbers 30406 and 30406-01 due to calibration problems using low calibrator S1. Affected lots may show decreased strip signals over time.
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
BioMérieux is recalling specific lots of VIDAS LH tests because they may become less accurate over time, leading to invalid calibration results when using low calibrator S1. This could affect test reliability for luteinizing hormone measurements.
The tests may show decreased signal strength over time for certain lots, causing invalid calibration when low calibrator S1 is used. This leads to unreliable luteinizing hormone measurements in blood samples.
Users of VIDAS LH tests for luteinizing hormone testing in human serum or plasma are affected. Those using the specific lots mentioned in the recall are most at risk of inaccurate test results.
Check for reference numbers 30406 or 30406-01 on the test packaging. Look for specific lot numbers: 1006041520 (exp. 10/06/2018), 1005940920 (exp. 08/06/2018), 1006041540 (exp. 10/06/2018), 1006212740 (exp. 12/21/2018), or 1006274770 (exp. 01/29/2019).
Look for lot numbers 1006041520, 1005940920, 1006041540, 1006212740, or 1006274770 on the test packaging.
BioMérieux recalls specific lots of VIDAS LH tests because internal tests showed decreased strip signals over time, leading to invalid calibration when using low calibrator S1.
The recall record does not specify a remedy, so no action is required beyond checking if your test has the listed lot numbers.
The recall indicates potential inaccurate test results, but no health risks are mentioned. The hazard is related to test accuracy, not direct injury.
We’ve drafted a message you can send BioMérieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2588-2018 — BioMérieux BioMérieux Hello, I own a BioMérieux that is covered by recall Z-2588-2018 from BioMérieux. 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.
