Z-2209-2023Class II

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

Name: Z-2209-2023 RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting...
Creator: Cytocell Ltd.
Published: 2023-05-24
License: https://open.fda.gov/license/

Cytocell Limited / initiated 2023-05-24 / Open, Classified / root cause: manufacturing process

FDA source

Cytocell Ltd. began a recall of RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome on 2023-05-24. FDA classified it as Class II and gives the reason as "DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2209-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-24
Posted: 2023-07-20
Recalling firm: Cytocell Limited
Product: RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 60 units
Distribution: US Nationwide distribution in the states of CA, FL, OH, & SC.
Product codes and lots: Catalog No. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2209-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2209-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20
Z-2210-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)