FDAClass IIMay 20, 2020

iQ200 Series Urine Microscopy Analyzer- All recall

iQ200 Series Urine Microscopy Analyzer- All part numbers

Why was iQ200 Series Urine Microscopy Analyzer- All recalled?

A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

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?

Catalog Numbers: 00-3322, 700-3325, 700-3326, 700-3345, 700-3347, 700-3370, 700-3375, 700-3300RFB, B48999, C10683, C10684., All part numbers

Product
iQ200 Series Urine Microscopy Analyzer- All part numbers
Recalling firm
Beckman Coulter Inc.
Quantity
3576 units
Distribution
US Distribution: Nationwide Foreign Distribution: Worldwide
Recall date
May 20, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls