Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues
Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.
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 where reduced stability may lead to inaccurate patient results, posing a risk of harm through improper medication management, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 13,751 units of Dimension TACR Flex reagent cartridges (DF107). The TACR method is an in vitro diagnostic test used to measure Tacrolimus levels in human whole blood, which aids in managing therapy for kidney and liver transplant patients.
The recall was initiated because Siemens confirmed that the TACR method may demonstrate reduced on-board stability. This issue may result in imprecise and inaccurate quality control and patient results.
The affected products were distributed nationwide, including in Alaska, Alabama, Arkansas, Arizona, California, the District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. The specific lot numbers involved are GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267, and FB3267.
The recalled product
- Product
- Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 13,751
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 (8)
- Siemens Material Number 10444938
- lot numbers GB3099
- GA3120
- DB3141
- GB3162
- GB3176
- FA3197
- FA3267 and FB3267.
Distribution
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