Fresh Recalls

FDAClass II · Medical device · Recall Z-1980-2026 · Recalled May 6, 2026

Dimension Creatinine Flex reagent cartridge recall — Siemens Healthcare Diagnostics, Inc.

Agency report date: May 6, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Dimension Creatinine Flex reagent cartridge
Company / brand
Siemens Healthcare Diagnostics
Lot / serial / date codes
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.
Agency product description and boundaries

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Dimension Creatinine Flex reagent cartridge

3. Open the official notice or contact

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

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
Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved August 4, 2026 at 11:00 PM UTC.

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