Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
FDA Recall Z-1053-04 · Posted 2004-07-20
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeMMI
Date Initiated2004-06-07
Date Terminated2005-04-18
Product Quantity5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04)
Reason for Recall
Random occurrence of false positive test results.
Firm Action
Domestic: Phone calls on 6/7-8/2004. Recall letters sent Federal Express on 6/7/2004. Foreign affiliates notified via e-mail on 6/7/2004. Customers instructed to discard inventory and notify health care providers. EXPANDED: Domestic: 7/1/2004 phone calls and faxes to consignees. FED EX letters mailed on 7/2/2004. Foreign affiliates notified via email on 6/30/2004.
Root Cause
Other
Distribution Pattern
4,665 reagent packs shipped to domestic customers nationwide, including 8 federal government accounts (contract #V797P-6565A). 520 reagent packs shipped to 22 foreign affiliates who further distributed the product to: Asia Pacific, Canada, Caribbean, Chile, China, France, Germany, Italy, Mexico, Spain, UK and Northern Europe. EXPANDED: 440 reagent packs shipped to 13 domestic customers and 1,067 reagent packs shipped to 22 foreign affiliates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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