Z-2209-2023 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
60 units

Product Description

RET Proximal 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. LPS508-A; UDI-DI: 05055844900509; Lot No. 076763, 077253, 080125, 080763, 082128, 083041, 083246, 083555.