Z-1318-2010

Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay...

Name: Z-1318-2010 Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay...
Creator: Beckman Coulter Inc.
Published: 2010-02-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-06 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340... on 2010-02-06. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained with...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1318-2010
Status: Terminated
Initiated: 2010-02-06
Posted: 2010-04-12
Terminated: 2012-05-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 The intended use: The Access AccuTnI 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 also 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.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained with UniCel Dxl systems have been demonstrated to have a positive bias compared to values obtained with Access or Access 2 systems.
FDA root cause: Other
Action: An "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated February 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers are recommended to immediately discontinue using AccuTnI Reagents and Calibrators on the UniCel DxI system until further notice. If this is not possible, the customers are directed to notify their stakeholders of the bias until further notice. The customers should complete, fax (786-639-4000) or mail the enclosed RESPONSE FORM. If consignees need assistance or have any questions regarding the notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.
Quantity in commerce: 196,071 kits
Distribution: Worldwide distribution: USA and Canada
Product codes and lots: Lot Numbers: 716707, 720541, 720542, 721451, 721452, 722677, 722678, 821024, 821025, 821515, 821663, 823314, 823523, 823524, 823850, 825783, 825784, 826258, 826259, 827876, 828479, 829974, 831218, 850000, 850003, 850004, 850005, 850010, 850011, 850013, 908322, 908323, 908917, 908918, 909803, 909804, 911338, 911339, 911748, 912628, 912629, 913131, 913132, 913265, 913274, 913500, 913821, 914632, 915132, 915417, 915670, 915850, 916720, 916721, 916721A, 917611, 918460 Note: These Lot Numbers represent all reagent lots released to field that could be used in conjunction with Unicel DxI Access Immunoassay Systems.

Product code MMI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)