FDA-Device2019-07-10Class III
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Roche Diagnostics Corporation
Hazard
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Sold states
US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA
Affected count
4 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief