—#153922

Product

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 product code: JIS — Calibrator, Primary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K103836
Affected lot / code info: Lots 6JD079 and 6MD042

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2017-02-23
Posted by FDA: 2017-03-15
Terminated: 2018-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153922. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.