Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
Lot Codes / Batch Numbers
Lot numbers: 069915, 070433, 069305, 069468
Products Sold
Lot numbers: 069915, 070433, 069305, 069468
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom is recalling Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026