FDA Recall of MicroScan Neg MIC 56 Due to Contamination
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Beckman Coulter, Inc. is voluntarily recalling 685 boxes of MicroScan Neg MIC 56 panels because of potential contamination in the wells, affecting nationwide distribution in several U.S. states.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 9, 2026 and geographically references United States. 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.
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FDA Recall of MicroScan Neg MIC 56
What Happened
Beckman Coulter, Inc. initiated a recall due to the likely presence of contamination in the wells of the MicroScan Neg MIC 56 panels. This is classified as a Class II recall.
Which Products Are Affected
The affected product is MicroScan Neg MIC 56, with reference number REF C42464 and UDI-DI code 15099590731212. The recall involves 685 boxes with lot number 2026-01-03. Distribution occurred nationwide in the United States, specifically in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX. The official recall number is Z-1609-2026.
What You Should Do
Consumers who have the affected product should check for the catalog number C42464, UDI-DI code 15099590731212, and lot number 2026-01-03. Contact Beckman Coulter, Inc. at their address, 2040 Enterprise Blvd, West Sacramento, CA 95691-3427, as initial notification was made via letter for further instructions on returns or refunds.
Why This Matters
This recall is significant because the contamination could affect the accuracy of antimicrobial susceptibility testing for certain bacteria, potentially impacting patient safety in healthcare settings. It highlights the importance of quality control in medical devices distributed across multiple states.
Source
This information is from the FDA recall database, attributed to the U.S. Food and Drug Administration (FDA). For more details, refer to FDA recall event ID 98555.
Original source: FDA Official Notice ↗
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