Clinical Diagnostic Systems recalls VITROS TSH reagent packs with specific lots due to higher than expected calibrator signals causing calibration issues. Affected lots expired by May 2018.
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
Clinical Diagnostic Systems is recalling specific lots of VITROS TSH reagent packs because they cause calibration errors in some lab systems. This could lead to inaccurate test results if the reagent is used without correction.
The reagent lots generate higher than expected signals for Calibrator Level 2, which can cause calibration curves to fall outside acceptable quality parameters. This may lead to inaccurate test results but does not cause immediate harm.
Lab users with the affected VITROS TSH reagent lots (lots 5470, 5430, and 5178) are most at risk. These lots were sold in the US and expired by May 2018.
Check the lot number on the reagent pack: 5470 (expired May 2018), 5430 (expired March 2018), or 5178 (expired March 2017). These lots were distributed in the US.
Identify the lot number on the VITROS TSH reagent pack to see if it matches 5470, 5430, or 5178.
The VITROS TSH reagent lots generate higher than expected Calibrator Level 2 signals, causing calibration curves to fall outside acceptable quality parameters.
Lots 5470 (expired May 2018), 5430 (expired March 2018), and 5178 (expired March 2017).
The recall does not require immediate stop use; lab users should check the lot number and verify if the reagent is affected.
We’ve drafted a message you can send Clinical Diagnostic Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1322-2018 — Clinical Diagnostic Systems Clinical Diagnostic Systems Hello, I own a Clinical Diagnostic Systems that is covered by recall Z-1322-2018 from Clinical Diagnostic Systems. 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.
