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Terminated

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

FDA Recall Z-0824-2022 · Posted None

Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodePPM
Date Initiated2022-02-14
Date Terminated2023-06-12
Product Quantity5 kits

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.

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].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of CT, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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