Analyst¿ MD Version 1 — Class II medical device recall Z-1586-2016
Terminated recall by Ab Sciex, reported 2016-05-11, distributed nationwide. Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an inco
| Recall number | Z-1586-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ab Sciex, Framingham, MA, United States |
| Recall initiated | 2016-02-24 |
| Classified | 2016-04-29 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CN, DE, ES, FR, GB, IE, IN, IT, KR, MY, NL, NO, RU, SG |
| Quantity | 279 |
| Model numbers | 3200MD, 5024500, 5024501, 5031231, 5031257 |
Product
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Reason for recall
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
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-1586-2016. 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.