Z-2135-2013Class II

ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3...

Name: Z-2135-2013 ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3...
Creator: Siemens Healthcare Diagnostics
Published: 2013-07-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-07-30 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x... on 2013-07-30. FDA classified it as Class II and gives the reason as "Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2135-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-09-03
Terminated: 2017-02-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established ranges of CAP Survey Samples GH2-04, GH2-05 and GH2-06 and IFCC sample recoveries use 7% from the established mean as their acceptance criteria. This is the criterion that was used during testing to confirm the customer complaints. Depending upon quality control limits this issue may not have been detected..
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Urgent Medical Device Correction letter dated July 30, 2013, to all affected customers via FedEx (for US consignees). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use and discard any of the affected reagent kit lots. Customers werealso requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative for questions. For questions regarding this recall call 914-524-2955.
Quantity in commerce: US: 1546 units; Foreign: 518 units
Distribution: Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to Argentina, Austria, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hungary, Indonesia, Italy, Kazakhstan, Lithuania, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, South Africa, South Korea, Thailand, Turkey, Uruguay, Vatican City, and Vietnam.
Product codes and lots: Lots 1MD014 (exp. date 5/01/2013), 1BD063 (exp. 5/01/2013), 2GD014 (exp. 10/01/2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2135-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2135-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03

Product code LCP

K081895Class IIAdvia Chemistry Hemoglobin A1c, Advia Chemistry A1c CalibratorsSiemens Medical Solutions Diagnostics / cleared 2009-01-08

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)