Beckman Coulter AutoMate Sorters Recalled for Sample Cross-Contamination Risk
Beckman Coulter is recalling 83 AutoMate and Automate sorter systems due to a risk of sample cross-contamination when a connection time-out occurs with the Laboratory Information System.
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 and involves a risk of harm (sample cross-contamination) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling 83 units of the AutoMate 1250, Sorter with Aliquot Module (Model #ODL25125) and the Automate 2550, High Speed Sorter with Aliquot Module (Model #ODL25255). The recall affects all units containing software Version 4.1.1 and up. These systems were distributed in New York and Virginia in the United States, as well as in Austria, Belgium, the Czech Republic, France, Germany, Israel, Italy, Lithuania, Mayotte, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
The recall was initiated after Beckman Coulter identified a case where a customer using the microltiterplate kit option without a sorting drive encountered cross-contamination of samples. This issue occurred when a connection time-out happened between the system and the Laboratory Information System (LIS). The agency has classified this as a Class II recall.
Customers should contact Beckman Coulter for instructions on how to address the software issue. The source text does not specify a specific action for consumers other than the identification of the defect.
The recalled product
- Product
- AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 83
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)
- All units containing software Version(s) 4.1.1 and up
Distribution
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