Z-0777-2023 Class II Ongoing
FDA device recall Z-0777-2023 was initiated by Beckman Coulter, Inc. on Nov 18, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 3657 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3657 units
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
Distribution Pattern
US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Code Information
UDI/DI 10837461002611, Lot 565-21: 11-30-2022
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0777-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026