FDA Device recall Z-1670-2016
ADVIA Chemistry Triglyceride_2, concentrated
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of ADVIA Chemistry Triglyceride_2, concentrated by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1670-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-07 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA, CO, CT, FL, KS, MI, MN, NC, NM, NY, OK, OR, TN, TX, UT, WA |
Product
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Reason
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
Identifiers
| code_info | Kit lots 348297 & 359932. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1670-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.