High FDA (Devices)·Z-2609-2014·Announced 2014-09-17

Ab Sciex API 3200MD System Recalled for Incorrect Diagnostic Data

Ab Sciex is recalling six API 3200MD LC/MS/MS systems because the MultiQuant 3.0 software may provide incorrect data for patient diagnosis.

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 data, representing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Ab Sciex is recalling six units of the API 3200MD LC/MS/MS System equipped with MultiQuant 3.0 software. The recall is due to the potential for the software to provide incorrect data used for patient diagnosis.

The affected systems are in vitro diagnostic devices used to identify inorganic or organic compounds, such as lead, mercury, and drugs, in human specimens. The recall covers six specific units with serial numbers BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, and BV20131401. These units were distributed in Florida, North Carolina, Oklahoma, Pennsylvania, and Texas.

Healthcare facilities and users of these systems should stop using the affected equipment and contact Ab Sciex for further instructions on the recall.

The recalled product

Product: AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.
Manufacturer: Ab Sciex
Category: Medical Device — In Vitro Diagnostic
Hazard: incorrect-data
Affected units: 6

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 (6)

Serial Numbers: BV20031308
BV20081311
BV20051310
BV20071311
BV20101401
BV20131401

Distribution

Distributed in 5 states:

Same manufacturer · Ab Sciex

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Same hazard · incorrect data