Quick Facts at a Glance
- Recall Date
- May 7, 2026
- Hazard Level
- HIGH
- Brand
- Siemens Healthcare Diagnostics
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Healthcare Diagnostics
- Model numbers
- 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.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 7, 2026
Reported by FDA DEVICE
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Healthcare Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay. Reason: A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.. Classification: Class II. Quantity: 2878 units. Distribution: Worldwide distribution - 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.
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Safety Guide
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