Recall Z-1053-04 ยท MMI Immunoassay Method, Troponin Subunit
Ortho-Clinical Diagnostics
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.
| Date | Jul 20, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | Random occurrence of false positive test results. |
| Root cause | Other |
| 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. |
| Quantity | 5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04) |
| Distribution | 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031031 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc., Sep 29, 2003 |