Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Brand
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
Lot Codes / Batch Numbers
Catalog No. LPS509-A, UDI-DI: 05055844900516, Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
Products Sold
Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom is recalling RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for dete due to DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Recommended Action
Per FDA guidance
Customers were sent a recall notification dated 05/24/2023 informing them of this recall event. Customers are asked to identify any affected devices in stock and quarantine any devices from recalled lots. Affected devices are to be destroyed by customers. Additionally, customers are encouraged to review results obtained utilized affected devices to ensure that no results were misinterpreted due to the incorrect labeling of the DNA. Customers are to return the provided response form by fax to +44(0)1223294048 or by email to vigilance@ogt.com. Customers with any questions can contact Cytocell by phone at +44(0)1223294048, by fax at +44(0)1223294986, or by email at 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