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Terminated

Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

FDA Recall Z-0298-04 · Posted 2004-01-06

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJHX
Date Initiated2003-11-26
Date Terminated2004-02-20
Product Quantity774 reagent packs

Reason for Recall

Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

Firm Action

Customers notified via phone and faxed letter on 11/26/03. Customers provided with a modified QC procedure to be used until new shipments can be made.

Root Cause

Other

Distribution Pattern

738 reagent packs shipped to U.S. consignees and 36 reagent packs to Canadian consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993068VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSOrtho-Clinical Diagnostics · 1999-10-04

Official Source

View FDA Recall →

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

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