MicroScan Neg MIC 56 Contamination Recall Z-1609-2026
Summary
Beckman Coulter, Inc. issued a Class II medical device recall for MicroScan Neg MIC 56 (REF C42464) due to likely contamination in well(s) of the antimicrobial susceptibility testing panels. The recall affects product distributed nationwide across 12 states including CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX. The UDI-DI code is 15099590731212. The recall is ongoing.
What changed
Beckman Coulter initiated a Class II recall for MicroScan Neg MIC 56 antimicrobial susceptibility testing panels due to the likely presence of contamination in well(s). The contamination poses a risk of inaccurate susceptibility testing results, which could lead to inappropriate antimicrobial therapy decisions. The product was distributed to clinical laboratories and healthcare facilities across 12 U.S. states.
Healthcare providers and clinical laboratories using these MicroScan panels should immediately identify any affected products in their inventory, cease use pending further instructions from Beckman Coulter, and contact the manufacturer for return/replacement procedures. The accuracy of antimicrobial susceptibility testing is critical for appropriate antibiotic selection and patient treatment outcomes.
What to do next
- Identify and quarantine affected MicroScan Neg MIC 56 (REF C42464) products with UDI-DI 15099590731212
- Contact Beckman Coulter for return/replacement instructions
- Notify affected laboratories and healthcare providers using these panels
Archived snapshot
Apr 11, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Beckman Coulter, Inc.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1609-2026 · 20260401 · Ongoing
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...
Reason for Recall
Due to the likely presence of contamination in well(s).
Distribution
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Source: openFDA Enforcement API
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