Recall Z-0855-2007 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Laboratories MPG
ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jun 14, 2007 (initiated Mar 8, 2007) |
| Status | Terminated |
| Reason | False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL |
| Root cause | Other |
| Action | Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of = 0.01 ng/mL might not be met for all lots of Architect STAT Troponin-I reagents. The accounts were directed to evaluate the information the information provided in the letter against the reference range used in their laboratory to determine if any action needs to be taken; to follow their facility's policies and procedures for communicating with the heath care providers they serve; to forward |
| Quantity | 9,438 kits |
| Distribution | Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Trindad & Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics, Aug 12, 2004 |