Recall Z-1509-2012 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the AR
| Date | May 10, 2012 (initiated Apr 11, 2012) |
| Status | Terminated |
| Reason | The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating. |
| Root cause | Material/Component Contamination |
| Action | The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required"letter dated April 11, 2012 to all Troponin-I customers who received the affected reagent lot internationally. The customers were directed to determine if they are currently using and/or have inventory of lot 74264UN11; to discontinue use and destroy any remaining inventory of the lot; to follow their facility's policies and procedures for communicating with the heath care providers they serve; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; to retain a copy of the let |
| Quantity | 8,723 kits |
| Distribution | International distribution only: including countries of: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia & Herze, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics, Aug 12, 2004 |