Dimension Creatinine Flex Reagent Cartridge Recalled for Imprecision Results
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine test results that could be erroneously increased or decreased.
What this means for you
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: This is an FDA Class II recall with no reported illnesses or injuries mentioned in the source. The hazard is a potential imprecision in test results rather than a confirmed failure, making this a moderate precautionary action warranting timely correction but not meeting criteria for higher severity.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 18,080 units of Dimension Creatinine Flex reagent cartridges (Material Number 10872079, Model DF33B) with lot numbers GA6307 and BA7005. The recall affects units distributed worldwide, including nationwide in the United States and internationally to Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines, Qatar, Saudi Arabia, Serbia, Slovenia, South Africa, Sri Lanka, Taiwan, Thailand, the United Arab Emirates, Ukraine, Uruguay, Vietnam, and Yemen.
The cartridges are being recalled because of a potential imprecision in quality control and patient sample results on the Dimension System. This imprecision may cause creatinine patient results to be erroneously decreased or increased.
Healthcare facilities using affected lot numbers should contact Siemens Healthcare Diagnostics for instructions on replacement cartridges and proper handling of affected units.
The recalled product
- Product
- Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- test-imprecision
- measurement-error
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 (2)
- (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307
- BA7005.
Distribution
Distributed nationwide across the United States.
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