Recall Z-1995-2010 ยท MMI Immunoassay Method, Troponin Subunit
Beckman Coulter Inc.
Access Immunoassay Systems enhanced AccuTnl Reagent Kit; Part Number: A78803 The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin
| Date | Jul 12, 2010 (initiated Mar 11, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because as a follow up to PCA # 12605 dated December 16, 2009, Beckman Coulter has confirmed additional reports that each of the following assays may produce lower than expected results when run in conjunction with Access AccuTnl (REF A78803): (1) Access Testosterone (REF 33560); (2) Access Thyroid Uptake (REF 33810); (3) Access Total T4 (REF 33800). This issue can occ |
| Root cause | Other |
| Action | The firm, Beckman Coulter, issued a "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with attached Customer Response form dated March 24, 2010 to all customers. The letter describes the issue, impact, action and resolution. In the PCA beckman Coulter recommends the following mitigation to reduce the risk of generating erroneous results: (1) Verify the APF software on the immunoassay system. If the updated APF software listed in the table above was already loaded , skip the remainder of this section and proceed to the Resolution section; (2) If the updated APF software has not yet been loa |
| Quantity | 32,407 units |
| Distribution | Worldwide distribution: USA and countries of Algeria, Australia, Bangladesh, Belgium, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Lebanon, Libyan Arab Jamahiriya, Monaco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Puer |
| FDA record | Open on fda.gov |