Device 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.
Z-2210-2023
Product summary
- Firm
- Cytocell Ltd.
- Event
- Event 92586
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-2210-2023
Official wording
Reason: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Code information: Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.
Distribution pattern: US Nationwide distribution in the states of CA, FL, OH, & SC.
Derived failure modes
-
Unknown
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.