RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating

FDA device recall Z-2209-2023 · posted 2023-07-20 · Open, Classified

Recall details

Recalling firm

Cytocell Ltd.

Reason for recall

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

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.

Root cause

Process control

Status

Open, Classified

Product code

MVU

Quantity affected

60 units

Distribution

US Nationwide distribution in the states of CA, FL, OH, & SC.

Date initiated

2023-05-24

Date posted

2023-07-20

Location

Cambridge, United Kingdom