Siemens Tacrolimus Reagent Cartridge Recalled for Low Sample Recovery
Siemens is recalling 2,976 Dimension Tacrolimus Flex reagent cartridges due to confirmed low patient sample recovery and a 25% low bias compared to LC/MS.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a diagnostic accuracy issue (low bias) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall involving potential adverse health consequences due to inaccurate results.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,976 units of the Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The affected lots are FA3085 (exp 2013-03-26) and FA3316 (exp 2013-11-12). The product is an in vitro diagnostic test used to measure tacrolimus levels in patient samples.
The recall was initiated after Siemens confirmed customer complaints regarding low patient sample recovery with lot FA3085. Internal method regression testing against LC/MS (liquid chromatography-mass spectrometry) revealed an average 25% low bias across the assay range. Quality Control materials did not exhibit low recovery of the same magnitude, but the bias affects individual patients, particularly those with lower TACR values.
The product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA. Users should stop using the affected cartridges and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,976
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 (4)
- Lot numbers FA3085
- exp 2013-03-26
- and FA3316
- exp 2013-11-12
Distribution
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