—#33662

Product

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 product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K031031
Affected lot / code info: Lot 1110 and Lot 2510 with exp. date of 8/11/04. EXPANDED 6/30/04 to include Lot 1130 and Lot 2530 with exp. date of 9/8/2004.

Why it was recalled

Random occurrence of false positive test results.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14626-5101

Distribution

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.

Timeline

Recall initiated: 2004-06-07
Posted by FDA: 2004-07-20
Terminated: 2005-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.