Z-0626-2014Class II

HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical...

Name: Z-0626-2014 HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-04-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-04-22 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R)... on 2013-04-22. FDA classified it as Class II and gives the reason as "Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed". 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-0626-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-22
Posted: 2014-01-03
Terminated: 2014-02-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an Urgent Medical Device Recall letter in April 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discard any remaining inventory of the affected product. Siemens will replace any unused inventory at no charge. Customers were asked to complete the attached form and fax it to 302-631-8467 to indicate they have received the information. Customers were asked to retain the letter with their laboratory records and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 1-800-441-9250.
Quantity in commerce: 11006 Total
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
Product codes and lots: Catalog number K3105A (Siemens Material Number 10470481) - Lot numbers 12072AA, exp. 2/9/13: 12086AA, exp. 2/23/13:12107AA, exp. 3/16/13; 12128AA, exp. 4/6/13; 12150AA, exp. 4/28/13; 12191AA, exp. 6/8/13; 12212AA, exp. 6/29/13; 12226AA, exp. 7/13/13; 12248AA, exp. 8/4/13; 12261AA, exp. 8/17/13; 12282AA, exp. 9/7/13; 12303AA, exp. 9/28/13.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0626-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0625-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-03
Z-0626-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-03

Product code LCP

K102045Class IIDimension Visa Hba1c, Model K3105aSiemens Heatlhcare Diagnostics, Inc. / cleared 2011-02-14

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)