Beckman Coulter MicroScan gram-negative panels may contain contaminated wells
Beckman Coulter is recalling one lot of MicroScan Neg MIC 56 panels due to the likely presence of contamination in one or more wells.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: contamination in the wells can distort antimicrobial susceptibility results, and no injuries are stated in the source.
Plain-English summary
Beckman Coulter, Inc. is recalling the MicroScan Neg MIC 56, REF C42464. MicroScan panels are designed for determining antimicrobial agent susceptibility and identification to species level of aerobic and facultatively anaerobic gram-negative bacilli. About 685 boxes were distributed across 12 US states. The FDA has classified this recall as Class II.
The recall was initiated due to the likely presence of contamination in one or more wells.
Affected product carries UDI-DI 15099590731212 and lot number 2026-01-03.
Laboratories can identify affected panels by the catalogue number, UDI and lot number above, and may contact Beckman Coulter, Inc. for further information.
The recalled product
- Product
- MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 685
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: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Distribution
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