FDA Recall of MicroScan Neg Multidrug Resistant MIC 1 by Beckman Coulter
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, Inc. is voluntarily recalling 3 boxes of MicroScan Neg Multidrug Resistant MIC 1 due to a manufacturing issue affecting the in vitro multidrug resistant test.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 23, 2026 and geographically references Poland. 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, cpsc, 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 MicroScan Neg Multidrug Resistant MIC 1 product due to a manufacturing issue involving incorrect processing of the in vitro multidrug resistant test.
Which Products Are Affected
The affected product is MicroScan Neg Multidrug Resistant MIC 1 with REF C32368, UDI-DI code 15099590720568, and Lot Number 2026-05-08. A total of 3 boxes are involved in this recall. The product was distributed internationally to Poland.
What You Should Do
Consumers should follow the initial firm notification, which was a letter, for further instructions on this voluntary recall.
Why This Matters
This recall involves a medical device used for antimicrobial susceptibility testing, which could impact accurate diagnostics if the manufacturing issue affects performance; it is classified as Class II, indicating potential for temporary or reversible health consequences.
Source
This information is from the FDA recall database, attributed to FDA recall number Z-1794-2026.
Original source: FDA Official Notice ↗
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