Agency classClass IIOur severity:High FDA (Devices)·Z-1258-2023·Announced 2023-03-22

Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

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: This is an FDA Class II recall with confirmed imprecision in a critical drug-monitoring diagnostic test. While no illnesses or injuries have been reported, the defect poses significant risk of harm—incorrect tacrolimus measurements could result in organ rejection or toxicity. The severity score reflects substantial potential harm without reported actual injury.

Plain-English summary

Siemens Healthcare Diagnostics is recalling Dimension Tacrolimus (TAC) Flex reagent cartridges (lots GA2286, GA3047, and GA3171). These in vitro diagnostic tests measure tacrolimus levels in whole blood on Dimension clinical chemistry systems. A total of 6,035 units have been distributed worldwide and nationwide.

Siemens has confirmed imprecision in both quality control and patient samples, particularly at the low end of the measurement range. One patient sample that should have measured 2.0 ng/mL read as 0.0 ng/mL (100% negative bias), while another that should have measured 2.1 ng/mL read as 4.3 ng/mL (103% positive bias).

Tacrolimus is an immunosuppressant drug used in transplant patients. Incorrect measurement results could lead to improper dosing, potentially resulting in organ rejection if tacrolimus levels are too low or toxicity if levels are too high. The health consequences of erroneous results are described as major.

Customers using the affected cartridge lots should contact Siemens Healthcare Diagnostics, Inc. for guidance regarding the recalled product.

The recalled product

Product: Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In vitro diagnostic test
Hazard: measurement-error
incorrect-dosing
organ-rejection
toxicity
Affected units: 6,035

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 (5)

UDI: 00842768035425GA228622101310700795840
00842768035425GA304723021610700795840
00842768035425GA317123062010700795840. Lot Numbers: GA2286
GA3047
GA3171

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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