FDA recall, , Moderate risk
Siemens Healthcare Diagnostics Dimension Creatinine Flex Reagent Cartridge
This imprecision may lead to erroneously decreased or increased creatinine patient results.
Summary by Recall Canary from the FDA notice
What happened
The reagent cartridge may have imprecision in quality control and patient sample results. This imprecision may lead to erroneously decreased or increased creatinine patient results.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Dimension Creatinine Flex reagent cartridge
- UDI-DI
- 10872079
- 00630414595009
- 20261103
- 20270105
- Lot code
- GA6307
- BA7005
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, 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, U.A.E., Ukraine, Uruguay, Vietnam, Yemen.
- Company
- Siemens Healthcare Diagnostics, Inc.Newark, Delaware
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98666
- Recall number
- Z-1980-2026
- Quantity recalled
- 18,080 units
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
