Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.
FDA Recall Z-0299-04 · Posted 2004-01-06
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDHX
Date Initiated2003-12-03
Date Terminated2004-02-20
Product Quantity524 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
U.S. customers notified via FED EX letter sent on 12/3/03. Letter includes modified QC procedures to use until replacement product is issued. Foreign affiliates notified via e-mail on 12/3/03 with instructions to notify customers.
Root Cause
Other
Distribution Pattern
154 reagent packs shipped to consignees in the U.S. 370 reagent packs shipped to Ortho/J&J International Affiliates for further distribution to foreign users. Foreign consignees are located in Argentina, Australia, Belgium, Brazil, Chile, China, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Portugal, Puerto Rico, Singapore, Spain, United Kingdom, and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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