The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0625-2014·Announced 2014-01-15

Siemens HB1C Flex Reagent Cartridges Recalled for Positive Bias

Siemens Healthcare Diagnostics is recalling HB1C Flex Reagent Cartridges due to positive bias and frequent 'Above Assay Range' flags.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 device with a risk of harm (inaccurate diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling HB1C Flex(R) Reagent Cartridges (DF105A, Siemens Material Number 10483822) used with the Dimension(R) Clinical Systems. These in vitro diagnostic assays are used for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood to monitor long-term glucose control in individuals with diabetes mellitus.

The recall is due to positive bias on the affected lots compared to alternate methods and a higher frequency of 'Above Assay Range' flags. A total of 11,006 units were distributed nationwide in the United States and internationally to Canada and Mexico. The affected lots include GA3099, GA3141, GA3197, GA3247, GA3113, GA3162, GB3211, GA3267, GA3134, GA3169, GA3232, GB3281, and GC3302, with expiration dates ranging from April 9, 2013, to October 29, 2013.

Healthcare facilities and consumers should stop using the affected reagent cartridges and contact Siemens Healthcare Diagnostics for further instructions or a replacement.

The recalled product

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…
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
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 DF105A (Siemens Material Number 10483822) - Lot numbers GA3099
  • exp. 4/9/13
  • GA3141
  • exp. 5/21/13
  • GA3197
  • exp. 7/16/13
  • GA3247
  • exp. 9/4/13
  • GA3113
  • exp. 4/23/13
  • GA3162
  • exp. 6/11/13
  • GB3211
  • exp. 7/30/13
  • GA3267
  • exp. 9/24/13
  • GA3134
  • exp. 5/14/13
  • GA3169
  • exp. 6/18/13

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.

See all 2 products in this recall →

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