Agency classClass IIOur severity:High FDA (Devices)·Z-0796-2023·Announced 2023-01-11

Measles Antibody Test Kits Recalled Due to Temperature Excursion

Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a FDA Class II recall of a diagnostic device where temperature excursion has compromised product performance. Although no illnesses or injuries have been reported, the recall represents a risk of harm through inaccurate test results. Per the rubric, risk-of-harm products without reported injury receive a score of 3 (High).

Plain-English summary

Biomerieux Inc is recalling VIDAS Clinical VIDAS Measles IgG 60 Tests (Catalog 30219) distributed nationwide in the United States due to temperature and time excursions that exceeded acceptable limits during storage or transportation.

When diagnostic test kits experience such excursions, chemical reagents and test components may degrade, potentially affecting test accuracy and reliability. The manufacturer states that product performance cannot be guaranteed for affected units.

The recall involves 5 units with Batch Number 1009421810. Affected healthcare facilities, laboratories, or individuals should contact Biomerieux Inc to determine whether they received recalled product and to arrange for replacement or return.

The recalled product

Product: VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
Manufacturer: Biomerieux Inc
Category: Medical Device — Clinical Diagnostic Test
Hazard: storage-excursion
performance-degradation
inaccurate-results
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UDI/DI 03573026064532
Batch Numbers: 1009421810

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 94 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 94 products in this recall →

Same manufacturer · Biomerieux Inc

See all →

High
Biomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
High
VITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
High
Susceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
High
Antimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
Severe
VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01

Same hazard · storage excursion