Z-1712-2017Class III

ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture

Name: Z-1712-2017 ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-02-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-02-23 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2017-02-23. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1712-2017
Classification: Class III
Status: Terminated
Initiated: 2017-02-23
Posted: 2017-03-15
Terminated: 2018-05-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: JIS Calibrator, Primary
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by 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.
Quantity in commerce: 314 calibrators
Distribution: 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
Product codes and lots: Lots 6JD079 and 6MD042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1712-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1712-2017	Class III	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-04

Product code JIS

K103836Class IIEnzyme II CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2011-02-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)