Agency classClass IIOur severity:High FDA (Devices)·Z-0040-2024·Announced 2023-10-11

Mass Spectrometer Recalled for Risk of Flame and Electrode Ejection

AB Sciex is recalling 14 Citrine Triple Quad Mass Spectrometers (Part Number 5063684) due to rare risk of solvent leak and electrical discharge potentially causing flame and electrode ejection at the ion source probe.

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: This is a risk-of-harm product involving flammable solvent and electrical discharge hazards with potential for fire and electrode ejection. No illnesses or injuries have been reported, and the source explicitly states the condition occurs only in rare circumstances. Per the severity rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3.

Plain-English summary

AB Sciex, LLC is recalling 14 Citrine Triple Quad Mass Spectrometer units (Part Number 5063684) distributed nationwide in the United States. These units are identified by UDI-DI 00842365100533 and specific serial numbers from DE220001803PL through DE240042203.

In rare circumstances, a combination of solvent leakage at the ion source probe and electrical discharge can create a flame on the probe. The electrode assembly may be ejected from the probe. If left unattended, this flame poses potential risks to the operator, customer property, and the environment. The malfunction also causes delays in obtaining patient test results.

This recall affects laboratory and clinical facilities using these instruments. Users should stop using affected units immediately and contact AB Sciex, LLC for repair instructions. The FDA classified this recall as Class II.

The recalled product

Product: Citrine Triple Quad Mass Spectrometer, Part Number 5063684
Manufacturer: AB Sciex, LLC
Category: Medical Device — Laboratory Instrument
Hazard: fire
electrical-discharge
solvent-leak
electrode-ejection
Affected units: 14

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 (15)

UDI-DI: 00842365100533
Serial Numbers: DE220001803PL
DE230011804
DE230031806
DE230041807
DE230051808
DE230071901
DE230081903
DE230091903
DE230162003
DE230272105
DE230292105
DE240002106
DE240022111
DE240042203

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

See all →

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Same hazard · fire