Z-1450-06

Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests

Name: Z-1450-06 Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests
Creator: Bayer Healthcare, LLC (Diagnostics Division)
Published: 2006-02-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-02-17 / Terminated

FDA source

Bayer Healthcare, LLC (Diagnostics Division) began a recall of Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests on 2006-02-17. The reason FDA records is "Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1450-06
Status: Terminated
Initiated: 2006-02-17
Posted: 2006-08-29
Terminated: 2012-05-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.
FDA root cause: Other
Action: Bayer HealthCare LLC issued a Support Bulletin to all affected Bayer HealthCare LLC Branches on/about 2/17/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Customer Bulletins were also issued to the Branches both in the United States and elsewhere for communication with the affected customers.
Quantity in commerce: 1138 for all products
Distribution: Worldwide including USA and Puerto Rico.
Product codes and lots: Part No. 073-A010; all Advia Chemistry System units are serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.

Product code JGS

K990346Class IIBayer Advia 1650 Chemistry SystemBayer Corp. / cleared 1999-05-21

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)