Dimension — Class II medical device recall Z-0517-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-12-25, distributed nationwide. Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in impr
| Recall number | Z-0517-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-04-25 |
| Classified | 2013-12-16 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 13,751 |
| Reason classes | specification failure |
| Lot numbers | DB3141, FA3197, FA3267, FB3267, GA3120, GB3099, GB3162, GB3176 |
Product
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients
Reason for recall
Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0517-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.