AB Sciex Triple Quad 4500MD LC/MS/MS System — Class II medical device recall Z-1671-2016
Terminated recall by Ab Sciex, reported 2016-05-25, distributed in NC. Under certain conditions, mass spectrometers may report incorrect quantitative results.
| Recall number | Z-1671-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ab Sciex, Framingham, MA, United States |
| Recall initiated | 2016-03-25 |
| Classified | 2016-05-15 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2016-05-23 |
| Distributed | NC |
| Quantity | 2 units |
| Model numbers | 5031231, 5031257 |
Product
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
Reason for recall
Under certain conditions, mass spectrometers may report incorrect quantitative results.
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-1671-2016. 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.