FDA recall Z-0824-2022

Product

Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

Reason for recall

Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.

Distribution

US Nationwide distribution in the states of CT, TX.

Key facts

Status

Terminated

Initiation date

2022-02-14

Report date

2022-03-30

Termination date

2023-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0824-2022