Recall Z-0353-2023 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
| Date | Dec 1, 2022 (initiated Oct 27, 2022) |
| Status | Terminated |
| Reason | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert |
| Root cause | Under Investigation by firm |
| Action | Cytocell issued Urgent Medical Device Recall letter on 10/27/22 to the end-user via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Once implemented, all devices can continue to be used as the device itself has not malfunctioned. Please complete and return the enclosed response form as soon as possible. If you have any questio |
| Distribution | TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.