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U.S. Department of Health and Human Services

Class 2 Device Recall RET Proximal Probe

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  Class 2 Device Recall RET Proximal Probe see related information
Date Initiated by Firm May 24, 2023
Date Posted July 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2209-2023
Recall Event ID 92586
Product Classification Reagents, specific, analyte - Product Code MVU
Product RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Code Information Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.
Recalling Firm/
Manufacturer		 Cytocell Ltd.
418 Cambridge Science Park, Milton Road
Oxford Gene Technology
Cambridge United Kingdom
For Additional Information Contact Ana Castro-Justo
44-122-3294048
Manufacturer Reason
for Recall		 DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 60 units
Distribution US Nationwide distribution in the states of CA, FL, OH, & SC.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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