FDAClass IIApril 4, 2018

Quanta-lyser 240 IFA recall

QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide…

Why was Quanta-lyser 240 IFA recalled?

The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.

What should I do if I have this product?

Review the official FDA enforcement record for current 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 number 4314

Product
QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide…
Recalling firm
Inova Diagnostics Incorporated
Quantity
1 instrument
Distribution
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls