CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report

MicroScan Neg MIC 3J recalled by Beckman Coulter

Beckman Coulter is recalling MicroScan Neg MIC 3J. The recall was initiated on 25 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23

Quantity recalled688 boxes (20 panels per box)

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-1772-2026
FDA event ID: 98553
Recalling firm: Beckman Coulter, West Sacramento, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Jun 2025
FDA classified: 3 Apr 2026
Reported: 15 Apr 2026
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Jun 2025	Recall initiated by company
3 Apr 2026	Classified by FDA	+282 days
15 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 a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

Product as listed by the FDA

MicroScan Neg MIC 3J REF C54814

Where it was distributed

International distribution in the country of Japan.

Questions about this recall

Why was it recalled?

Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

Which lots are affected?

Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23

Where was it sold?

International distribution in the country of Japan.

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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