FDAClass IIDecember 20, 2017

UniCel DxH800 recall

UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer

Why was UniCel DxH800 recalled?

The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

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 Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151

Product
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Recalling firm
Beckman Coulter Inc.
Quantity
15 units
Distribution
CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Recall date
December 20, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls