FDAClass II · Medical device · Recalled May 6, 2026
Dimension Creatinine Flex reagent cartridge recall — Siemens Healthcare Diagnostics, Inc.
Hazard: 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
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-1980-2026
- Brand
- Siemens Healthcare Diagnostics
- Classification
- Class II
- Units affected
- 18,080 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Affected products
Companies & origin
- Recalling firm location
- Newark, DE, United States
- Firm address
- 500 Gbc Dr, 19702-2466
Identifying details (verbatim from the notice)
- Product codes / lots
- Material Number: 10872079. Model Number: DF33B. UDI: (01)00630414595009(10)GA6307(17)20261103, (01)00630414595009(10)BA7005(17)20270105. Lot Numbers: GA6307, BA7005.
- Distribution
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 98666
- Recall initiated
- March 18, 2026
- FDA classified
- April 28, 2026
- FDA report date
- May 6, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 1:09 AM UTC.
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