Medical device recalls

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

Recall date
February 14, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0824-2022
FDA classification
Class III
Brand / firm
Cytocell Ltd.
Sold / distributed
US Nationwide distribution in the states of CT, TX.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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