Beckman Coulter IRISpec CA/CB/CC control recall
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.
Why was Beckman Coulter IRISpec CA/CB/CC control recalled?
IRISpec CA failures for glucose.
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?
Lot #583-21 and higher, UDI 10837461002611.
- 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.
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 12,306 kits
- Distribution
- Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.
- Recall date
- April 27, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)