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Terminated

VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

FDA Recall Z-0913-05 · Posted 2005-06-21

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeKLI
Date Initiated2005-03-15
Date Terminated2006-02-10
Product QuantityDomestic - 1359; International - 840

Reason for Recall

Potential for positively biased results in QC and patient samples.

Firm Action

Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.

Root Cause

Other

Distribution Pattern

Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964721VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)Johnson & Johnson Clinical Diagnostics, Inc. · 1996-12-18

Official Source

View FDA Recall →

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

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