ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
FDA Recall Z-1712-2017 · Posted 2017-03-15
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIS
Date Initiated2017-02-23
Date Terminated2018-05-09
Product Quantity314 calibrators
Reason for Recall
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
Firm Action
Siemens mailed an Urgent Medical Device Correction Notice to affected customers on 02/21/2017. The notice informed calibrator customers of the reason for the correction, risk to health, and actions to be taken by customers who are in the process of converting from the fixed factor to the enzyme calibrated assay and information for customers who had already converted, until the investigation is complete.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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