CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
Dimension Creatinine Flex reagent cartridge recalled
Siemens Healthcare Diagnostics is recalling Dimension Creatinine Flex reagent cartridge, distributed nationwide in the US. The recall was initiated on 18 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1980-2026
- FDA event ID
- 98666
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2026
- FDA classified
- 28 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Mar 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +41 days |
| 6 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Product as listed by the FDA
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Which lots are affected?
Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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