Beckman Coulter Inc. has recalled 6,994 units in the U.S. and 10,067 units internationally of the Access PCT Reagent Pack (Catalog Number C53987) used with laboratory immunoassay systems. The identified reagent lots are experiencing a high rate of calibration failures, specifically showing a "Max Iterate" error code. While no injuries have been reported, this defect can cause significant delays in reporting patient test results, which may affect clinical decision-making. Laboratories should immediately stop using the affected lots and contact the manufacturer for a replacement or correction.
The reagent packs fail to calibrate correctly, preventing the system from producing accurate patient test results in a timely manner. These delays can postpone critical medical diagnoses or treatments for patients.
Used on Access 2 and UniCel Dxl Immunoassay Systems.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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