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Terminated

Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793

FDA Recall Z-0558-03 · Posted 2003-02-21

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Date Initiated2003-01-10
Date Terminated2003-06-03
Product Quantity284 cartons/2 bottles per carton

Reason for Recall

Label printing irregularities on cartons and/or bottles.

Firm Action

Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.

Root Cause

Other

Distribution Pattern

Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964310VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)Johnson & Johnson Clinical Diagnostics, Inc. · 1996-11-27

Official Source

View FDA Recall →

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

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