Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene
Brand
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
Lot Codes / Batch Numbers
Lots 072240, 071390, and 072693
Products Sold
Lots 072240, 071390, and 072693
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom is recalling Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled i due to Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green.
Recommended Action
Per FDA guidance
The firm began distributing recall notifications to customers on December 22, 2020. Customers were informed of the product issue. Customers were instructed to do the following: Immediately examine your inventory and quarantine all product subject to recall. The firm requests that you destroy the remaining inventory. The firm also suggests that laboratories review any results obtained with the affected devices and check that signal patterns were not misinterpreted as a result of any additional locus specific signal at 11q13. 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 noticeDistribution
As reported by FDA
CA, IL, MI, MN, NJ, TX, WA
Page updated: Jan 10, 2026