Z-0340-2016Class II

ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT...

Name: Z-0340-2016 ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-09-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-09-24 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the... on 2015-09-24. FDA classified it as Class II and gives the reason as "Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0340-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-24
Posted: 2015-11-25
Terminated: 2017-01-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias.
FDA root cause: Under Investigation by firm
Action: Siemens has issued an Urgent Medical Device Recall in the US and an Urgent Field Safety Notice Outside the US on September 24, 2015, instructing customers to discontinue use, discard reagent and request no charge replacement kits for these products.
Quantity in commerce: 3031
Distribution: Distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, and the countries of Mexico and Canada.
Product codes and lots: 10379673 (160 tests kit), 10485591 (800 tests kit) Lot 230 (SMN 10485591 and 10379673) and lot 231(SMN 10485591)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0340-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0340-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25

Product code LCP

K110934Class IIAdvia Chemistry Hemoglobin A1c_3 (A1c_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics / cleared 2011-08-25

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)