Beckman Coulter UniCel DxH Slidemaker Stainer Recall for Fitting Seal Defect
Beckman Coulter is recalling 310 UniCel DxH Slidemaker Stainer units because a fitting may not completely seal after installation.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc. is recalling 310 units of the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The recall is due to a defect where a fitting in some units may not completely seal after installation.
The affected units were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Brazil, Canada, and the United Kingdom. The product is used to produce and stain blood smears for microscopic examination to help determine a patient's hematologic status.
The source text does not specify instructions for consumers or healthcare facilities on how to proceed with the recall, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 310
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)
- P/N A85371AA20
- Catalog No. 775222
Distribution
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