FDA Recall of Siemens Dimension Creatinine Flex Reagent Cartridge
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridges due to potential imprecision in creatinine results, affecting 18,080 units distributed nationwide and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
FDA Recall of Siemens Dimension Creatinine Flex Reagent Cartridge
What Happened
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge because of a potential imprecision in the Dimension CRE2 quality control and patient sample results. This imprecision may lead to erroneously decreased or increased creatinine patient results using specific lot numbers on the Dimension System.
Which Products Are Affected
The affected product is the Dimension Creatinine Flex reagent cartridge with Material Number: 10872079. The specific lot numbers are GA6307 and BA7005. The model number is DF33B, and the UDI codes are (01)00630414595009(10)GA6307(17)20261103 and (01)00630414595009(10)BA7005(17)20270105. A total of 18,080 units are affected, with distribution including US Nationwide and countries such as Argentina, Australia, and others. The recall was initiated on March 18, 2026, under recall number Z-1980-2026.
What You Should Do
Consumers who have the affected lots should follow the firm's initial notification, which was sent via letter, and contact Siemens Healthcare Diagnostics, Inc. at their address: 500 Gbc Dr, Newark, DE 19702-2466, for further instructions on returns or refunds.
Why This Matters
This recall involves medical devices that could produce inaccurate creatinine results, potentially affecting patient diagnoses and treatments in healthcare settings.
Source
Attribution: FDA. For more information, visit the FDA website and search for recall number Z-1980-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,552 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.