Recall Z-2209-2023 ยท MVU Reagents, Specific, Analyte
Cytocell Ltd.
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
| Date | Jul 20, 2023 (initiated May 24, 2023) |
| Status | Open, Classified |
| Reason | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| Root cause | 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 |
| Quantity | 60 units |
| Distribution | US Nationwide distribution in the states of CA, FL, OH, & SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.