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U.S. Department of Health and Human Services

Class 2 Device Recall Aquarius LPH 511A CRLF2 Distal Probe Green

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 Class 2 Device Recall Aquarius LPH 511A CRLF2 Distal Probe Greensee related information
Date Initiated by FirmDecember 22, 2020
Create DateFebruary 08, 2021
Recall Status1 Terminated 3 on June 07, 2022
Recall NumberZ-1099-2021
Recall Event ID 87090
Product Classification Reagents, specific, analyte - Product Code MVU
ProductAquarius 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
Code Information Lots 072240, 071390, and 072693
FEI Number 3002646096
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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.
Quantity in Commerce72
DistributionDomestic distribution to California, Illinois, Michigan, Minnesota, New Jersey, Texas, and Washington. Foreign distribution to Canada.
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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