Z-0824-2022Class III

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

Name: Z-0824-2022 Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Creator: Cytocell Ltd.
Published: 2022-02-14
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2022-02-14 / Terminated / root cause: labeling and UDI

FDA source

Cytocell Ltd. began a recall of Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 on 2022-02-14. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0824-2022
Classification: Class III
Status: Terminated
Initiated: 2022-02-14
Posted: 2022-03-24
Terminated: 2023-06-12
Recalling firm: Cytocell Limited
Product: Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Product code: PPM General Purpose Reagent
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.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 5 kits
Distribution: US Nationwide distribution in the states of CT, TX.
Product codes and lots: Lot 210511-018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0824-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0824-2022	Class III	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-24

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)