Recall Z-0777-2023— Beckman Coulter, Inc.

Name: FDA recall Z-0777-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-18

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2022-11-18. It names one FDA 510(k) clearance: K072640. Product: BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.. Reason: 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.

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-18
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K072640 — IRISPEC,CA/CB/CCIris Diagnostics·cleared 2007-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.