Siemens Dimension tacrolimus reagent cartridges may bias results positively
Three lots of the Siemens Dimension Tacrolimus Flex reagent cartridge are being recalled because of a potential positive bias in quality control and patient sample results.
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: FDA Class II recall with a stated positive bias in patient sample results for a therapeutic drug assay, a risk of harm with no injuries reported.
Plain-English summary
The Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795, an enzyme immunoassay, is being recalled. The action covers 2,878 units.
The stated reason is a potential positive bias in quality control and patient sample results in three lots of the cartridge. The FDA classified the action as Class II.
Affected manufacturing lots are FA6254, FA6260 and FA6286. Distribution was worldwide, including nationwide in the United States and to Argentina, Austria and other markets. The cartridges are supplied to laboratories rather than sold to consumers.
Laboratories should identify affected stock using the REF, SMN, lot numbers and UDIs in the recall notice and follow the instructions issued by Siemens, including any guidance on reviewing affected results.
The recalled product
- Product
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,878
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 (6)
- Manufacturing Lot/Serial Numbers: FA6254
- FA6260
- FA6286
- UDIs: (01)00842768035425(10)FA6254(17)20260911
- (01)00842768035425(10)FA6260(17)20260917
- (01)00842768035425(10)FA6286(17)20261013.
Distribution
Distributed nationwide across the United States.
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