# Biomerieux Inc recall opens medical devices buyers to alternatives (2026-09-30)

**Switch Opportunity Score:** 40/100

| Field | Value |
|---|---|
| Recalling firm | Biomerieux Inc |
| Product | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 |
| Replacement market | Medical devices |
| Agency | FDA medical devices |
| Severity | medium |
| Hazard | The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resista |
| Recall date | 2026-09-30 |
| Switch angle | Buyers and retailers of the recalled medical devices need a compliant replacement; position your product on the specific hazard fixed, with documentation. |
| Original recall record | /report/fdapulse/z-3231-2026 |

## Why this score
- Medium severity.

Source: CPSC, NHTSA and FDA device recalls (via our recall feeds), mapped to replacement markets (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3231-2026%22). Last refreshed: 2026-11-04T21:38:28.354Z.
Built from official CPSC, NHTSA and FDA recall data; market mapping is our classification. Do not make claims about a competitor's recall beyond what the agency published, and follow advertising and comparative-claims rules. Not a consumer report and may not be used for FCRA purposes. Informational only; not legal, investment or procurement advice. Not affiliated with any agency or company listed.