Class II recall Z-3231-2026: Biomerieux Inc
Class II recall Z-3231-2026: Biomerieux Inc (Missouri): Biomerieux Inc. Dated 35 days ago, it serves as a historical benchmark. Score 62/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 3 related MO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3231-2026 |
| Recalling firm | Biomerieux Inc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 |
| Reason | 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 resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health. |
| Quantity | 97680 units |
| Distribution | International distribution to the countries of Austria, Germany, Luxembourg. |
| Recall initiated | 2026-07-24 |
| Reported | 2026-09-30 |
| Firm location | Hazelwood, MO, United States |
| Peer records CSV (4 MO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (MO first): VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260 · VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K26 · Restrata (K261245) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Class II recall Z-3231-2026: Biomerieux Inc and 4 Missouri peers
- Missouri FDAPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Missouri peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 35 days ago.
What is the FDAPulse record for Class II recall Z-3231-2026: Biomerieux Inc in Missouri?
Class II device recall Z-3231-2026 by Biomerieux Inc: The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pou
How does Class II recall Z-3231-2026: Biomerieux Inc compare to other Missouri FDAPulse records?
It is 35 days old, still within a typical 45-day follow-up window.
Class II recall Z-3231-2026 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-3231-2026 | MO | 2026-09-30 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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