FDAClass IIIJuly 10, 2019

cobas p 501 post-analytical units recall

cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

Why was cobas p 501 post-analytical units recalled?

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from 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 Numbers - 1001 through 1044

Product
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Recalling firm
Roche Diagnostics Corporation
Quantity
4 units
Distribution
US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Recall date
July 10, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls