Beckman Coulter IRISpec CA Control glucose measurement failures recalled
Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification combined with no reported illnesses or injuries indicates lower risk. The hazard is a functional failure in a quality control product rather than an acute physical or biological safety threat.
Plain-English summary
Beckman Coulter, Inc. is recalling IRISpec CA/CB/CC control kits (Catalog #800-7211), which are laboratory quality control products used to verify the accuracy of diagnostic analyzers. Each kit contains three 100 mL bottles each of CA Control, CB Control, and CC Control.
The CA Control component is experiencing failures in glucose measurement, which affects the product's ability to function as intended for quality control verification in clinical laboratories.
Approximately 12,306 kits have been distributed worldwide, including throughout the United States, Puerto Rico, Brazil, Canada, Curaçao, Guatemala, Mexico, Philippines, Singapore, and Taiwan. The recall includes all lots numbered 583-21 and higher (UDI 10837461002611).
Laboratories and healthcare facilities using affected kits should discontinue use and contact Beckman Coulter for guidance on replacement products or alternative quality control measures.
The recalled product
- 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.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 12,306
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #583-21 and higher
- UDI 10837461002611.
Distribution
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