---
title: "VITEK 2 AST-N447 TEST KIT Product reference 424620 — FDA record Z-2715-2026 | Is It on Recall"
description: "Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures."
url: https://isitonrecall.com/recall/fda-device-z-2715-2026-vitek-2-ast-n447-test-kit-product-reference-424620/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# VITEK 2 AST-N447 TEST KIT Product reference 424620 — FDA record Z-2715-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: VITEK 2 AST-N447 TEST KIT Product reference 424620
- **Reason**: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
- **Classification**: Class II
- **Recalling firm**: Biomerieux Inc
- **Quantity**: 45,900 cards
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2715-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2715-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution to the countries of Belgium and the Netherlands.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jul 15, 2026
- **Recall initiation date**: Jun 4, 2026
- **Center classification date**: Jul 9, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2715-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Biomerieux Inc records](https://isitonrecall.com/brand/biomerieux-inc/)