FDA Recall of MicroScan Neg MIC 3J by Beckman Coulter

Source: FDA · Japan

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Beckman Coulter is voluntarily recalling 688 boxes of MicroScan Neg MIC 3J due to a manufacturing issue with missing and doubled antibiotics, affecting distribution in Japan.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 23, 2026 and geographically references Japan. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Beckman Coulter, Inc. is recalling the product due to a manufacturing issue where a drug is missing in well 4/4, but the panels contain double the amount of antibiotics.

Which Products Are Affected

The affected product is MicroScan Neg MIC 3J with reference number C54814. The recall involves 688 boxes, each containing 20 panels. The catalog number is C54814, UDI code is N/A, and the lot number is 2025-08-23. Distribution was international, specifically in the country of Japan.

What You Should Do

Consumers should contact the recalling firm, Beckman Coulter, Inc., for instructions regarding the recall, using the recall number Z-1772-2026.

Why This Matters

This recall addresses a potential manufacturing defect that could impact the accuracy of medical tests, highlighting the importance of quality control in medical devices to ensure patient safety.

Source

FDA recall notice Z-1772-2026, attributed to the U.S. Food and Drug Administration.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Beckman Coulter is voluntarily recalling 688 boxes of MicroScan Neg MIC 3J due to a manufacturing issue with missing and doubled antibiotics, affecting distribution in Japan.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Japan. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.