FDA Medical Device Recalls (openFDA)
Cytocell Ltd.: RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
- Recall number
- Z-2210-2023
- Recalling firm
- Cytocell Ltd.
- Product
- RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
- Status
- Open, Classified
- Initiated
- 2023-05-24
- Posted
- 2023-07-20
- Terminated
- not on file
- Reason
- DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
- 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 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.
- Quantity
- 61 units
- Distribution
- US Nationwide distribution in the states of CA, FL, OH, & SC.
- Lot, serial or model codes
- Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 3002646096
- Firm city
- Cambridge
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28