FDA DevicesClass II
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107007...
Published: June 17, 2026Recall ID: Z-2398-2026Category: devicesCountry: US
Reason for Recall / Hazard
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
Product Description & Identification
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Additional Source Details
| Field | Value |
|---|---|
| City | Newark |
| State | DE |
| Event id | 98985 |
| Address 1 | 500 Gbc Dr |
| Address 2 | N/A |
| Code info | 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. |
| Postal code | 19702-2466 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 2878 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260507 |
| Initial firm notification | Letter |
| Center classification date | 20260610 |
Overview
- Recalling FirmSiemens Healthcare Diagnostics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.