BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Reported: January 11, 2023 Initiated: November 18, 2022 #Z-0777-2023
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
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 3657 units
- Distribution
- US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.. Recalled by Beckman Coulter, Inc.. Units affected: 3657 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0777-2023.
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