Device product
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Z-0824-2022
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 89747
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 kits
- Official record key
device-enforcement:Z-0824-2022
Official wording
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.
Code information: Lot 210511-018
Distribution pattern: US Nationwide distribution in the states of CT, TX.
Derived failure modes
-
Unknown
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.