Recall Z-2323-2021 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
| Date | May 27, 2021 |
| Status | Terminated |
| Reason | May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34 |
| Root cause | Nonconforming Material/Component |
| 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 vi |
| Quantity | 23 units |
| Distribution | US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.