CLASS II ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
MicroScan Neg MIC recalled by Beckman Coulter
Beckman Coulter is recalling MicroScan Neg MIC 56, distributed nationwide in the US. The recall was initiated on 24 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1609-2026
- FDA event ID
- 98555
- Recalling firm
- Beckman Coulter, West Sacramento, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2025
- FDA classified
- 20 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2025 | Recall initiated by company | |
| 20 Mar 2026 | Classified by FDA | +239 days |
| 1 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to the likely presence of contamination in well(s).
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Nationwide CaliforniaColoradoIndianaMassachusettsMarylandMinnesotaMissouriNorth CarolinaNew JerseyOklahomaPennsylvaniaTexas
Questions about this recall
Why was it recalled?
Due to the likely presence of contamination in well(s).
Which lots are affected?
Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Where was it sold?
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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