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 Initiated
- May 24, 2023
- Posted
- July 20, 2023
- Recall Number
- Z-2210-2023
- Quantity
- 61 units
Reason for Recall
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Distribution
US Nationwide distribution in the states of CA, FL, OH, & SC.
Lot / Code Info
Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
Root Cause
Process control
Action Taken
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.