FDAClass IIDecember 20, 2017

UniCel DxH600 recall

UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench…

Why was UniCel DxH600 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 Number AZ06682

Product
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench…
Recalling firm
Beckman Coulter Inc.
Quantity
1 unit
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