Z-2086-2017Class II

ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic...

Name: Z-2086-2017 ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2017-04-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-04-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in... on 2017-04-05. FDA classified it as Class II and gives the reason as "Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance...". 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-2086-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-05
Posted: 2017-04-19
Terminated: 2019-04-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
Product code: CFP Radioimmunoassay, Immunoreactive Insulin
Reason for recall: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued a UMDC to ADVIA Centaur/XP/XPT/CP IRI customers on April 5, 2017. They were informed of the issue & that they may continue use of current product but should discontinue when corrected product is available (reagent lots ending in 201 with cal lots ending in 02). A shift down will occur with the corrected product. BioRad control ranges will be posted to QCnet.com for the corrected reagents.
Distribution: US OUS: Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Hungary, Italy, Luxembourg, Latvia, Netherlands, Norway, Greece, Croatia, Poland, Portugal, Romania, Sweden, Slovak Republic, Turkey
Product codes and lots: Kit Lots Ending: 169, 170, 173, 174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2086-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2085-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12
Z-2086-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code CFP

K021535Class IIAdvia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp. / cleared 2002-06-27

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)