MicroScan susceptibility panels recalled over missing drug and doubled antibiotic
Beckman Coulter is recalling MicroScan Neg MIC 3J panels because a manufacturing issue left one well missing a drug while containing double the amount of antibiotics.
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: FDA Class II recall of an antimicrobial susceptibility panel with an incorrect drug composition, which can produce unreliable results and creates a risk of harm with no injuries reported.
Plain-English summary
Beckman Coulter, Inc. is recalling the MicroScan Neg MIC 3J, catalog number C54814, lot 2025-08-23. The action covers 688 boxes at 20 panels per box.
The recall is due to a manufacturing issue: well 4/4 is missing a drug but contains double the amount of antibiotics. The panels are used to determine antimicrobial agent susceptibility, so a well that does not contain the intended drug at the intended concentration can produce unreliable susceptibility results. The FDA classified the action as Class II.
Distribution was international, to Japan. The panels are used in clinical laboratories rather than sold to consumers.
Laboratories should identify affected stock using the catalog number and lot number above, quarantine it, and follow the instructions issued by Beckman Coulter.
The recalled product
- Product
- MicroScan Neg MIC 3J REF C54814
- 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)
- Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
Distribution
Distribution scope not specified by the agency.
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