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Terminated

Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

FDA Recall Z-2782-2016 · Posted 2016-09-12

Recalling FirmClark Laboratories, Inc. (dba,Trinity Biotech USA)
Recall StatusTerminated
Product CodePCL
Date Initiated2016-07-11
Date Terminated2017-05-09
Product QuantityUS: 6 kits, Foreign: 50 kits

Reason for Recall

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).

Firm Action

Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distribution to US nationwide including California, and China (Hong Kong).

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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