Trinity Biotech Usa

Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

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).

Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.

Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.

Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

lack of 510K

lack of 510K

lack of 510K

lack of 510K