RET Distal Probe. Used in Fluorescence in situ… recallZ-2210-2023 · Cytocell Ltd. · initiated May 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cytocell Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-2210-2023
- Status
- Open, Classified
- Initiated by the company
- May 24, 2023
- Posted by the FDA
- Jul 20, 2023
- Recalling firm
- Cytocell Ltd.
- Quantity
- 61 units
- Product code
- MVU
- Distribution
- US Nationwide distribution in the states of CA, FL, OH, & SC.
Product description
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Code information (models, lots, serial numbers)
Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CytoCell LPS509-ACytocell Limited · Reagents, Specific, Analyte1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92586).
- Z-2209-2023 · Open, ClassifiedRET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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