FDA recall Z-0777-2023

Product

BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

Reason for recall

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

Distribution

US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

Key facts

Status

Ongoing

Initiation date

2022-11-18

Report date

2023-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0777-2023