Dimension Tacrolimus Flex reagent cartridge — Class II medical device recall Z-1924-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-08-14, distributed nationwide. Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex
| Recall number | Z-1924-2013 |
|---|---|
| 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 | 2013-07-01 |
| Classified | 2013-08-07 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2014-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 5,423 |
| Reason classes | potency |
| Lot numbers | 3BD029, BB4087 |
| Expiration dates | 2014-03-01, 2014-03-28 |
Product
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension 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 initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
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-1924-2013. 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.