Recall Z-2134-2021 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
| Date | May 17, 2021 |
| Status | Terminated |
| Reason | The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall notification letter dated 5/17/21 was sent to customers. Actions to be taken by [Customer/User] 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 20p12/13. Corrective and Preventative Actions: Cytocell are currently investigating how this issue occurred and wil |
| Quantity | 50 |
| Distribution | Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.