Recall

Class II — Siemens Healthcare Diagnostics, Inc.

Recalling firm	SIEMENS HEALTHCARE DIAGNOSTICS INC.
Registered facility	View this company's 12 registered facilities → (openFDA recall records do not name a specific facility)
Classification	Class II
Status	Terminated
Reason	Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
Product	HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) 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.
Quantity	11006 Total
Distribution	Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
Initiated	2013-04-22
Classified	2014-01-03
Terminated	2014-02-12
Recall number	Z-0625-2014
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0625-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65409/

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