MicroScan multidrug resistance test panels recalled over incorrect processing
MicroScan Neg Multidrug Resistant MIC 1 panels are being recalled because of a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test. Three boxes are affected.
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 test affected by a processing error, which can produce unreliable results and creates a risk of harm with no injuries reported.
Plain-English summary
MicroScan Neg Multidrug Resistant MIC 1, catalog number C32368, UDI-DI 15099590720568, lot 2026-05-08, is being recalled. The action covers three boxes.
The panels are used with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels to determine antimicrobial agent susceptibility. The recall is due to a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test. The FDA classified the action as Class II.
Distribution was international, to Poland. The panels are used in clinical laboratories rather than sold to consumers.
Laboratories should identify affected stock using the catalog number, UDI-DI and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial…
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 3
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: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Distribution
Distribution scope not specified by the agency.
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