Z-2210-2023 Class II Ongoing

Recalled by Cytocell Ltd. — Cambridge, N/A

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.