FDA recall Z-1345-2022

Product

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

Reason for recall

High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

Distribution

CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,

Key facts

Status

Ongoing

Initiation date

2022-05-20

Report date

2022-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntingdon Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1345-2022