Beckman Coulter Access BR Monitor Recalled for Potential Result Bias
Beckman Coulter is recalling Access BR Monitor units because French quality controls indicated potential result biases for cancer patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors for cancer patients, which is a risk-of-harm product scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling the Access BR Monitor, Part No. 387620, following biases observed in the results of the French National Quality Controls. The recall affects 45,278 units total, with 2,419 units distributed in the United States.
A study completed by the French Competent Authority, Agence nationale de sécurité du Médicament et des produits de santé (ANSM), indicated that diagnosed cancer patients in non-remission of their metastatic disease may have results below the upper reference limit of 31.3 U/mL. This limit is stated in the Access BR Monitor instructions for use.
The recall covers specific lot codes 623913, 625701, 628771, 630349, 633070, and all future lots. The affected geographies include the United States and numerous international locations. Users should contact Beckman Coulter for further instructions regarding the recall.
The recalled product
- Product
- Access BR Monitor, Part No. 387620
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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 (5)
- 623913
- 625701
- 628771
- 630349
- 633070 and All Future Lots
Distribution
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