CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) recalled
Siemens Healthcare Diagnostics is recalling Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), distributed nationwide in the US. The recall was initiated on 7 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2398-2026
- FDA event ID
- 98985
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 May 2026
- FDA classified
- 10 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 May 2026 | Recall initiated by company | |
| 10 Jun 2026 | Classified by FDA | +34 days |
| 17 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Where it was distributed
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.
Questions about this recall
Why was it recalled?
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Which lots are affected?
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 was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Siemens Healthcare Diagnostics
All 694| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS III | Syva Emit Disopyramide Assay Enzyme Immunoassay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS III | Syva Emit tox Serum Tricyclic Antidepressant recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,658| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |