ADVIA Chemistry Triglyceride_2 — Class II medical device recall Z-1670-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-05-25, distributed in CA, CO, CT, FL, KS, MI, MN, NC…. Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) do
| Recall number | Z-1670-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2016-03-07 |
| Classified | 2016-05-13 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-12-01 |
| Distributed | CA, CO, CT, FL, KS, MI, MN, NC, NM, NY, OK, OR, TN, TX, UT, WA |
| Countries outside the US | AT, AU, BE, BG, BR, CZ, DE, DK, EE, ES, FR, GB, IN, IT, LV, NO, NZ, PT, RO, SE, SI, SK, TH, TR |
| Reason classes | potency |
| Lot numbers | 348297, 359932 |
| Model numbers | 10697575 |
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 for recall
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.
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-1670-2016. 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.