Siemens Dimension — Class II medical device recall Z-0957-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-03-27, distributed in AL, AZ, CA, DC, FL, LA, MD, MI…. Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA
| Recall number | Z-0957-2013 |
|---|---|
| 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 | 2012-11-27 |
| Classified | 2013-03-15 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2014-08-04 |
| Distributed | AL, AZ, CA, DC, FL, LA, MD, MI, MO, NC, NJ, NM, OH, OR, PA, TN, TX, UT, VA, WA |
| Quantity | 2,976 |
| Reason classes | potency |
| Lot numbers | FA3085, FA3316 |
| Expiration dates | 2013-03-26, 2013-11-12 |
Product
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Reason for recall
Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values
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-0957-2013. 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.