FDA Device recall Z-0957-2013
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107) by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0957-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-27 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AL, AZ, CA, DC, FL, LA, MD, MI, MO, NC, NJ, NM, OH, OR, PA, TN, TX, UT, VA, WA |
Product
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Reason
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
Identifiers
| code_info | Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0957-2013%22
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