CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
Qtrap¿ 4500MD LC/MS/MS System Mass Spectrometer recalled by Ab Sciex
Ab Sciex is recalling AB Sciex Qtrap¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use, distributed nationwide in the US. The recall was initiated on 16 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2529-2016
- FDA event ID
- 74520
- Recalling firm
- Ab Sciex, Framingham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2016
- FDA classified
- 12 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Jun 2016 | Recall initiated by company | |
| 12 Aug 2016 | Classified by FDA | +57 days |
| 24 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 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.
Where it was distributed
Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
Questions about this recall
Is Qtrap¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use recalled?
Yes. Ab Sciex recalled Qtrap¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use on 16 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2529-2016.
Why was it recalled?
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Which lots are affected?
Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
Where was it sold?
Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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