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Class 3 Device Recall Breakapart Probe |
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Date Initiated by Firm |
February 04, 2022 |
Create Date |
March 21, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0814-2022 |
Recall Event ID |
89669 |
Product Classification |
Reagents, specific, analyte - Product Code MVU
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Product |
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A |
Code Information |
Lot 074612 |
Recalling Firm/ Manufacturer |
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
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Manufacturer Reason for Recall |
May show unexpected locus specific signals in addition to those at 14q32.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Cytocell issued Urgent Medical Device Recall letter (VC/2022/005) to Distributor/End User
via email on 2/4/22 . 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 you destroy the remaining inventory. We also suggest that laboratories undertake a review of the results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signals at 9q34.
Please complete and return the enclosed response form as soon as possible.
If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com. |
Quantity in Commerce |
1 unit |
Distribution |
MN |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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