Agency classClass IIOur severity:High FDA (Devices)·Z-0039-2024·Announced 2023-10-11

Citrine QTRAP Mass Spectrometer Recalled for Flammable Solvent Fire Hazard

AB Sciex is recalling ten Citrine QTRAP Mass Spectrometer units due to potential flame and electrode ejection from flammable solvent leaks combined with electrical discharge.

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 source text does not report any actual illnesses, injuries, or hospitalizations. The hazard is described as potential and rare, making it theoretical rather than realized. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it in the High severity category per the rubric.

Plain-English summary

AB Sciex, LLC is recalling ten units of the Citrine QTRAP Mass Spectrometer (Part Number 5063685) due to a potential fire and equipment damage hazard. Under rare circumstances, a leak of highly flammable solvent at the ion source probe, combined with an electrical discharge, may result in a flame on the probe and possible ejection of the electrode assembly.

This hazard poses risks to users, patients, and the surrounding environment. If left unattended, the flame could cause personal injury, damage to the equipment, or damage to nearby property. Additionally, this malfunction causes delays in obtaining patient test results.

The recalled units have the following serial numbers: DD250051901, DD250172009, DD250182009, DD230001804, DD250111910, DD250132004, DD250091909, DD250101910, DD250192010, and CN10011707PT. These units were distributed nationwide in the United States.

Users of affected Citrine QTRAP Mass Spectrometer units should immediately discontinue use and contact AB Sciex, LLC for guidance on replacement, repair, or return options. Laboratories should verify their equipment serial numbers against the recall list to determine if their instruments are affected.

The recalled product

Product: Citrine QTRAP Mass Spectrometer, Part Number 5063685
Manufacturer: AB Sciex, LLC
Category: Medical Device — Analytical Instrument
Hazard: fire
burn-injury
property-damage
projectile-hazard
Affected units: 10

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 (11)

UDI-DI: 00842365100540
Serial Numbers: DD250051901
DD250172009
DD250182009
DD230001804
DD250111910
DD250132004
DD250091909
DD250101910
DD250192010
CN10011707PT

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by AB Sciex, LLC 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 →

Same manufacturer · AB Sciex, LLC

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Same hazard · fire