Beckman Coulter Irispec Ca/cb/cc Control recall
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Why was Beckman Coulter Irispec Ca/cb/cc Control 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 10837461002611, Lot 565-21: 11-30-2022
- Product
- BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 3657 units
- Distribution
- US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
- Recall date
- January 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)