FDAJuly 11, 2016device
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
What to do
FDA enforcement status: Terminated
Brands named
clark laboratories inc dba trinity biotech usaclarkclark laboratories
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCFlaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards2026-07-09
- CPSCGreenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to Risk of Serious Injury from Fire Hazard2026-07-09
- CPSCJunpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries; Sold on Amazon by JSNJ_Tech Store2026-07-02
- CPSCRowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards2026-07-02
- CPSCRaychy Children's Light Sneakers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Carina and Rambo2026-06-25
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
- FDAAl Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case2026-06-09
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