FDA Recall Open, Classified

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

Recall: Z-2209-2023 · Initiated May 24, 2023

Recall

Recall Number
Z-2209-2023
Event Number
92586
Firm
Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
FEI Number
3002646096
Product Code
MVU
Status
Open, Classified
Root Cause
Process control
Initiated
May 24, 2023
Posted
July 20, 2023

Description

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

Reason

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

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 [email protected]. Customers with any questions can contact Cytocell by phone at +44(0)1223294048, by fax at +44(0)1223294986, or by email at [email protected].

Distribution

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

Quantity

60 units