VITEK 2 AST-N447 TEST KIT Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Biomerieux Inc is recalling 45,900 VITEK 2 AST-N447 TEST KIT cards due to potential false resistant results for carbapenem and cephalosporin.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references Belgium and the Netherlands. 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Biomerieux Inc initiated a voluntary recall of VITEK 2 AST-N447 TEST KIT cards after identifying a potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from the affected lot that have pouch foil fractures.
Which Products Are Affected
The recall involves VITEK 2 AST-N447 TEST KIT, Product reference 424620, Lot 0853293604. A total of 45,900 cards are affected. The UDI-DI is 03573026634551. The product is not registered in the US and was distributed internationally to Belgium and the Netherlands. Recall number Z-2715-2026. Classification: Class II.
What You Should Do
Consumers and healthcare providers should contact Biomerieux Inc regarding the affected lots.
Why This Matters
This Class II recall addresses a risk of inaccurate antimicrobial susceptibility testing results that could affect treatment decisions.
Source
FDA recall Z-2715-2026, report date 20260715.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (953 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.