FDAClass IIOctober 11, 2023

API3200MD Mass Spectrometer recall

API3200MD Mass Spectrometer, Part Number 4466230

Why was API3200MD Mass Spectrometer recalled?

In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: EQ230011907, EQ230021911, EQ230001901

Product
API3200MD Mass Spectrometer, Part Number 4466230
Recalling firm
AB Sciex, LLC
Quantity
3
Distribution
US Nationwide.
Recall date
October 11, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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