Z-2210-2023 Class II Ongoing
FDA device recall Z-2210-2023 was initiated by Cytocell Ltd. on May 24, 2023 and is designated Class II. Reason for recall: DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. The recall status is ongoing. Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- May 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
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.
Reason for Recall
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, OH, & SC.
Code Information
Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.