FDA recall Z-1945-2020

Product

iQ200 Series Urine Microscopy Analyzer- All part numbers

Reason for recall

A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

Distribution

US Distribution: Nationwide Foreign Distribution: Worldwide

Key facts

Status

Terminated

Initiation date

2020-03-30

Report date

2020-05-20

Termination date

2023-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2020