PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 15, 2014 Initiated: April 22, 2013 #Z-0626-2014

Product Description

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.

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.

Details

Units Affected
11006 Total
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
Location
Newark, DE

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 11006 Total.
Why was this product recalled? ▼
Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2014. Severity: Moderate. Recall number: Z-0626-2014.

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