Z-2430-2020Class II

ADVIA Chemistry Calibrator

Name: Z-2430-2020 ADVIA Chemistry Calibrator
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-06-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-06-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Calibrator on 2020-06-05. FDA classified it as Class II and gives the reason as "Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH". 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-2430-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-05
Posted: 2020-06-26
Terminated: 2021-11-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Calibrator
Product code: NDW Assay, Porphyrin, Spectrophotometry, Lithium
Reason for recall: Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare Diagnostics sent a letter notification sent to customers dated June 10, 2020. As one of the short-term alternatives for customers, where regulations permit, Siemens has evaluated the use of the lyophilized RANDOX Calibration Serum Level 3 Lot 1024UE. (CAL 3) for generating DBIL_2/DBil_2 and TBIL_2/TBil_2 results until a new lot of unaffected Siemens Chemistry Calibrator is available.
Quantity in commerce: 1872 units
Distribution: US Nationwide Distribution
Product codes and lots: Lots: 534177 (including sublots A, B and C) 960742 UDI: (01)00630414223414(10)534177(17)20210930 (01)00630414223414(10)534177A(17)20211031 (01)00630414223414(10)534177B(17)20211231 (01)00630414223414(10)534177C(17)20220131 (01)00630414223414(10)534177D(17)20220331 (01)00630414223414(10)960742(17)20220531

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2430-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2430-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-26
Z-2431-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-01	2020-06-26

Product code NDW

K050374Class IIAdvia Ims Lithium AssayBayer Healthcare, LLC / cleared 2005-06-15

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)