Beckman Coulter Recalls Access Ferritin Calibrators Due to Incorrect Concentration
Beckman Coulter is recalling Access Ferritin Calibrators because they contain a calibration card with an incorrect S5 calibrator concentration.
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 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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C. The recall is being conducted because the kits contain a calibration card with an incorrect S5 calibrator concentration.
The affected product is identified by Lot No. 671094. A total of 889 kits were distributed worldwide, with 6 kits distributed in the United States. The product was also distributed to numerous countries including Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.
This is a Class II recall. Users should contact Beckman Coulter for further instructions regarding the return or replacement of the affected kits.
The recalled product
- Product
- Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
- 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 (1)
- Lot No. 671094
Distribution
Distribution scope not specified by the agency.
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