The Recall Desk
ModerateFDA (Devices)·Z-0800-2023·Announced 2023-01-11

VIDAS Quality Control Product Recalled for Storage Condition Deviation

Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—loss of performance guarantee due to storage condition deviation—rather than direct patient harm. This is consistent with a precautionary recall.

Plain-English summary

Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, Catalog 30706 (Batch 1009351560) nationwide in the United States. The product was distributed in 12-unit packages.

Storage temperature and time conditions for the affected units exceeded specified limits. As a result, the manufacturer cannot guarantee the product will perform to specifications.

This quality control product is used in clinical diagnostic laboratories as part of the VIDAS analyzer system. The nationwide distribution means affected units may be present in clinical labs across the United States.

The recalled product

Product
VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
Manufacturer
Biomerieux Inc
Category
Medical Device — Diagnostic Quality Control
Hazard
  • storage-deviation
  • performance-degradation

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 03573026121631
  • Batch Numbers: 1009351560

Distribution

Distributed nationwide across the United States.

Related recalls

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