FDA recall Z-1927-2019

Product

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

Reason for recall

There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

Distribution

US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

Key facts

Status

Terminated

Initiation date

2019-04-04

Report date

2019-07-10

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1927-2019