FDA Recall
Terminated
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Recall: Z-0824-2022
·
Initiated February 14, 2022
Recall
- Recall Number
- Z-0824-2022
- Event Number
- 89747
- Firm
- Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
- FEI Number
- 3002646096
- Product Code
- PPM
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- February 14, 2022
- Terminated
- June 12, 2023
Description
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Reason
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.
Action
Cytocell issued Urgent Medical Device Recall dated 2/14/22 via email. The letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that you destroy the remaining inventory. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].
Distribution
US Nationwide distribution in the states of CT, TX.
Quantity
5 kits