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Terminated

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

FDA Recall Z-2323-2021 · Posted None

Recalling FirmCytocell Ltd.
Recall StatusTerminated
Product CodeMVU
Date Initiated2021-05-27
Date Terminated2022-05-09
Product Quantity23 units

Reason for Recall

May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

Firm Action

Cytocell issued Urgent Medical Device Recall Users issued via email on 5/27/21. Letter states reason for recall, heath risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that you destroy the remaining inventory. We also suggest that laboratories undertake a review any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signal at 9q34. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

Official Source

View FDA Recall →

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

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