Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.
This recall has been terminated (originally issued July 17, 2020).
- Recall Initiated
- July 17, 2020
- Terminated
- September 30, 2020
- Recall Number
- Z-2829-2020
- Quantity
- 62 units
- Official Source
- View on FDA website ↗
Reason for Recall
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Lot / Code Info
Lot numbers: 069915, 070433, 069305, 069468
Root Cause
Under Investigation by firm
Action Taken
Cytocell issued Urgent Medical Device Recall Letter dated July 17,200 stating 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. Please complete and return the enclosed response form as soon as possible. We wish to sincerely apologise for any inconvenience caused as a result of this medical device recall. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.