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

Recall Z-0819-2015 — Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in h

U.S. FDA — Device Enforcement · United States · 2014-11-17 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0819-2015
Date of alert: 2014-11-17
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: 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.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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