Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- Recall Initiated
- May 27, 2021
- Terminated
- May 9, 2022
- Recall Number
- Z-2323-2021
- Quantity
- 23 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
Distribution
US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.
Lot / Code Info
Lots 073004 and 072518 (Probe lot 200918-006).
Root Cause
Nonconforming Material/Component
Action Taken
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 vigilance@ogt.com.