Agency classClass IIOur severity:High FDA (Devices)·Z-1586-2016·Announced 2016-05-11

Ab Sciex Analyst MD Software Recall for Incorrect Diagnostic Results

Ab Sciex is recalling Analyst MD software versions 1.6.1 and 1.6.2 because it may display wrong quantitative results, potentially leading to incorrect patient diagnoses.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 software defect that may lead to incorrect patient diagnoses, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Ab Sciex is recalling Analyst MD software versions 1.6.1 and 1.6.2. This software is used with specific mass spectrometer instruments, including the API 3200MD, 3200MD QTRAP, Triple Quad 4500MD, and QTRAP 4500MD LC/MS/MS Systems. These instruments are intended for in vitro diagnostic purposes to identify compounds in human specimens.

The recall is due to a defect where wrong quantitative results may be displayed in reports generated by the device. This error may potentially lead to an incorrect patient diagnosis. The affected units were distributed worldwide, including in the United States and internationally to countries such as Austria, Canada, China, France, Germany, India, Ireland, Italy, Korea, Malaysia, the Netherlands, Norway, Russia, Singapore, Spain, Switzerland, and the United Kingdom.

Users of this software should contact Ab Sciex for further instructions on how to resolve the issue. The source text does not specify the total number of affected units or report any specific injuries or illnesses.

The recalled product

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…
Manufacturer: Ab Sciex
Category: Medical Device — In Vitro Diagnostic Software
Hazard: incorrect-diagnosis
Affected units: 279

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 (1)

Software Versions: Version 1.6.1 and 1.6.2

Distribution

Distributed nationwide across the United States.

Same manufacturer · Ab Sciex

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Same hazard · incorrect diagnosis