—#90300

Product

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 I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K010429, K021814
Affected lot / code info: Lot Numbers: 911748, 913265, 913500, 915417, 915850, 916721, 916720, 916721A, 917611, 918533, 918666

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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 loaded, but is available, load the software appropriate for the system, skip the remainder of this section and proceed to the Resolution section; (3) If the updated APF software is not immediately available, please contact Technical Support at 1-800-854-3633 in the United States and Canada. Consignees outside the United States and Canada, contact their local Beckman Coulter Representative and follow the instructions below until the software has been loaded on their system. (a) Access and Access 2 users should batch process Access Testosterone, Thyroid Uptake, or Total T4 samples; (b) For UniCel DxI users, assign Access AccuTnI (REF A78803) to a different reagent pipettor(s) than Access Testosterone, Thyroid Uptake, or Total T4; (c) The Access Testosterone, Thyroid Uptake, or Total T4 results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. Abnormally low Access Testosterone, Thyroid Uptake, or Total T4 results from samples tested in conjunction with Access AccuTnI (REF A78803) should be reviewed in the context of other diagnostic tests. Customers were instructed that after loading the updated APF software, the Access AccuTnI assay (REF A78803, test code TropI, test ID 275) must be recalibrated. Recalibrate of the Access Testosterone, T

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: 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, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Swaziland, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

Timeline

Recall initiated: 2010-03-11
Posted by FDA: 2010-07-12
Terminated: 2012-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90300. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.