Siemens HbA1c Flex Reagent Cartridge Recall for Positive Bias
Siemens is recalling HbA1c Flex reagent cartridges due to positive bias and frequent out-of-range flags, which may affect diabetes monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device with a risk of inaccurate results that could affect patient management, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 11,006 HbA1c Flex reagent cartridges (Catalog number K3105A) used with the Dimension Clinical Systems. The recall covers specific lots distributed nationwide in the United States and internationally to Canada and Mexico.
The recall was initiated because the affected lots showed a positive bias compared to alternate methods and a higher frequency of "Above Assay Range" flags. These issues may result in inaccurate hemoglobin A1c measurements, which are used to monitor long-term glucose control in individuals with diabetes mellitus.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics, Inc. for further instructions on returns or replacements. The affected lot numbers and expiration dates are listed in the official recall documentation.
The recalled product
- 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 det
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 11,006
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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