Beckman Coulter AutoMate 2500 Chemistry Analyzer Recall for Sensor Defect
Beckman Coulter is recalling AutoMate 2550 and 1250 chemistry analyzers because a misaligned sensor may fail to detect missing pipette tips, posing a remote risk of cross-contamination.
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 cross-contamination of patient samples, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the AutoMate 2550 "High Speed" (Catalog Number ODL25255) and AutoMate 1250 "Standard" (Catalog Number ODL25125) chemistry analyzer sample processing and sorting systems. The recall affects 73 units in the United States, with worldwide distribution across numerous countries including Canada, the United Kingdom, and Germany.
The recall is due to a misaligned pipette tip sensor that poses a remote risk of cross-contamination. If the sensor fails to trigger a no-tip error, the system may pipette patient samples without pipette tips. This defect is classified as an FDA Class II recall.
Healthcare facilities and users should contact Beckman Coulter for instructions on how to address the defect. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 73
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 (20)
- All units in the AutoMate 2500 Family are affected
- Serial Numbers - 1107
- 4048
- 4055
- 4025
- 4052
- 4079
- 4091
- 4076
- 4072
- 4073
- 4074
- 4111
- 4097
- 1054
- 1055
- 1048
- 1049
- 1147
- ODL25125-1342
Distribution
Distributed nationwide across the United States.
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