Reported May 11, 2016 · Terminated
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments
Ab Sciex
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ab Sciex · 500 Old Connecticut Path · Framingham, MA · 01701-4574
Is this the product you have?
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments
4 of 4 products
| Model / number | Product as published |
|---|---|
5024501 | API 3200MD" LC/MS/MS System, Instrument |
5024500 | 3200MD QTRAP¿ LC/MS/MS System, Instrument |
5031257 | Triple Quad" 4500MD LC/MS/MS System, Instrument |
5031231 | QTRAP¿ 4500MD LC/MS/MS System, Instrument 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. |
- Lot codes and dates
- Software VersionsVersion 1.6.1 and 1.6.2
- Amount recalled
- 279
Where it was sold
- Nationwide
Why it was recalled
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
This product could cause temporary or reversible health problems — stop using it.
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