Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2782-2016 — Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

U.S. FDA — Device Enforcement · United States · 2016-07-11 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2782-2016
Date of alert
2016-07-11
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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