Recall Z-0984-2022— Beckman Coulter, Inc.
Class III · Ongoing
Class III FDA medical device recall by Beckman Coulter, Inc., initiated 2022-02-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.. Reason: IRISpec CA failures for glucose..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-02-16
- Firm location
- Miami, FL, United States
Product description
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
Reason for recall
IRISpec CA failures for glucose.
Data sourced from openFDA. This site is unofficial and independent of the FDA.