Class II — Ab Sciex
| Recalling firm | AB SCIEX |
|---|---|
| Registered facility | AB SCIEX LP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis. |
| 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 el… |
| Quantity | 279 |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM |
| Initiated | 2016-02-24 |
| Classified | 2016-04-29 |
| Terminated | 2017-02-06 |
| Recall number | Z-1586-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ab Sciex (Z-1586-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73433/
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