Recall Z-0420-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0420-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-30

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-09-30, terminated 2015-08-10. It names 2 FDA 510(k) clearances: K102510, K102045. Product: Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension 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: Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-30
Terminated: 2015-08-10
Firm location: Newark, DE, United States

510(k) clearances named in this recall

2 on FDA's record

K102510 — DIMENSIONS HB1C KIT, MODEL DF105ASiemens Healthcare Diagnostics·cleared 2011-05-13
K102045 — DIMENSION VISA HBA1C, MODEL K3105ASiemens Heatlhcare Diagnostics, Inc.·cleared 2011-02-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension 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

Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.

Data sourced from openFDA. This site is unofficial and independent of the FDA.