FDA recall Z-0914-2020

Product

iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

Reason for recall

Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

Distribution

Worldwide distributions.

Key facts

Status

Terminated

Initiation date

2019-10-28

Report date

2020-02-05

Termination date

2026-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0914-2020