API3200MD Mass Spectrometer Recalled for Potential Fire Risk
AB Sciex is recalling three API3200MD mass spectrometers due to a rare risk of fire and electrode ejection from a solvent leak combined with electrical discharge. The flame could cause injury to users or property damage.
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: FDA Class II recall for a fire hazard involving potential thermal injury to users. No illnesses or injuries have been reported, but the combination of solvent leak and electrical discharge presents a credible risk of harm, meeting the criteria for High severity.
Plain-English summary
AB Sciex, LLC is recalling three API3200MD mass spectrometers (Part Number 4466230) distributed nationwide in the United States. The affected units have serial numbers EQ230011907, EQ230021911, and EQ230001901.
In rare circumstances, a combination of a flammable solvent leak at the ion source probe and an electrical discharge can cause a flame to appear on top of the probe and possibly eject the electrode assembly. This presents a risk of injury to users and damage to property if left unattended.
The malfunction also causes a delay in patient test results.
The recalled product
- Product
- API3200MD Mass Spectrometer, Part Number 4466230
- Manufacturer
- AB Sciex, LLC
- Category
- Medical Device
- Affected units
- 3
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 (3)
- Serial Numbers: EQ230011907
- EQ230021911
- EQ230001901
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 →Related recalls
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