The Recall Desk
HighFDA (Devices)·Z-2529-2016·Announced 2016-08-24

Ab Sciex QTRAP 4500MD Mass Spectrometer Software Recall for Incorrect Results

Ab Sciex is recalling 28 QTRAP 4500MD mass spectrometers because MultiQuant MD software may display incorrect quantitative results when using the Sum Multiple Ions feature.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may provide incorrect diagnostic results, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Ab Sciex is recalling 28 units of the QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. The affected units are equipped with MultiQuant MD software versions 3.0, 3.0.1, and 3.0.2. The recall is due to a software defect where, under certain conditions, users may be presented with incorrect quantitative results when utilizing the Sum Multiple Ions feature.

The affected instruments were distributed worldwide, including in the United States and internationally to Canada, Austria, China, the Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, the UK, and Malaysia. These mass spectrometers are intended to identify inorganic or organic compounds, such as lead, mercury, and drugs, in human specimens for in vitro diagnostic purposes.

Users of the affected software should contact Ab Sciex for further instructions regarding the recall and potential corrective actions.

The recalled product

Product
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 spe
Manufacturer
Ab Sciex
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Software Version: MultiQuant MD 3.0
  • MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Ab Sciex under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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