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Open, Classified

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

FDA Recall Z-2210-2023 · Posted 2023-07-20

Recalling FirmCytocell Ltd.
Recall StatusOpen, Classified
Product CodeMVU
Date Initiated2023-05-24
Product Quantity61 units

Reason for Recall

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

Firm 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].

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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