Recall Z-0824-2022 ยท PPM General Purpose Reagent
Cytocell Ltd.
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
| Date | Feb 14, 2022 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| 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 vigilance@ogt.com. |
| Quantity | 5 kits |
| Distribution | US Nationwide distribution in the states of CT, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.