Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall
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, Inc. is recalling 2878 units of Dimension Tacrolimus Flex Reagent Cartridge due to potential positive bias in QC and patient sample results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 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, Devices.
What Happened
Siemens Healthcare Diagnostics, Inc. initiated a voluntary recall of the Dimension Tacrolimus Flex Reagent Cartridge due to a potential positive bias in quality control (QC) and patient sample results in three lots.
Which Products Are Affected
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay. Manufacturing Lot/Serial Numbers: FA6254, FA6260, FA6286. UDIs: (01)00842768035425(10)FA6254(17)20260911; (01)00842768035425(10)FA6260(17)20260917; (01)00842768035425(10)FA6286(17)20261013. 2878 units distributed worldwide, including US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates. Recall number Z-2398-2026.
What You Should Do
The recall was initiated voluntarily by the firm via letter. Contact Siemens Healthcare Diagnostics, Inc. at 500 Gbc Dr, Newark, DE 19702-2466 for additional information.
Why This Matters
This ongoing Class II recall involves immunoassay devices used in tacrolimus testing and affects patient sample results across multiple countries.
Source
FDA Event ID 98985, Recall Number Z-2398-2026
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 (1,271 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.