Z-0589-2017Class II

Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the...

Name: Z-0589-2017 Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-10-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-10-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct... on 2016-10-07. FDA classified it as Class II and gives the reason as "Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the...". 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-0589-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-07
Posted: 2016-11-16
Terminated: 2018-05-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens issued an Urgent Medical Device Correction in the US and an Urgent Field Safety Notice Outside the US beginning on October 6, 2016. Customers were notified of the issue and instructed to use the reassigned DBIL_2 calibrator value for Chemistry Calibrator Lot Numbers 680726, 680726A, 680726B, 680726C and 680726D. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days by faxing to the Customer Care Center at 312-275-7795. For questions regarding this recall call 914-631-8000.
Quantity in commerce: 10,614 units
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam
Product codes and lots: Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0589-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code JJY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)