Beckman Coulter Recalls Unpaired Lyophilized Chemistry Calibrator Lots
Beckman Coulter is recalling specific lots of lyophilized chemistry calibrators because unpaired lots were distributed, which may cause erroneous calibration results.
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. The hazard involves potential erroneous results and QC failures due to incorrect calibration, which is a significant risk but does not involve direct physical injury or death.
Plain-English summary
Beckman Coulter Inc. is recalling specific lots of Lyophilized Chemistry Calibrator Level 1. The affected lots are 6101K51 and 6101K61. These products are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers.
The recall was initiated because unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.
The affected products were distributed worldwide in the United States and in Brazil, Canada, Costa Rica, El Salvador, Guam, Paraguay, and Peru. Users should stop using the affected lots and contact Beckman Coulter for instructions on how to proceed.
The recalled product
- Product
- Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based…
- Manufacturer
- Beckman Coulter Inc.
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)
- Lots # 6101K51 and 6101K61
Distribution
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