The Recall Desk
ModerateFDA (Devices)·Z-0807-2023·Announced 2023-01-11

Biomerieux BIOBALL P.AERUGINOSA Quality Control Product Recalled for Temperature Excursion

Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.

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 medical device recall. Storage excursions prevent performance assurance. No reported illnesses, injuries, or clinical consequences are stated in the source text. This is consistent with a precautionary recall due to quality assurance issues.

Plain-English summary

Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 550X20 (Catalog 56017), a quality control product used in laboratory microbiology testing. The product was supplied in a quantity of 2 units.

The product was subject to temperature and time excursions that exceeded specified storage requirements. As a result, product performance cannot be guaranteed.

The recalled batch (number 7240) was distributed nationwide in the United States.

Users who have received this product should discontinue use of the recalled batch and contact Biomerieux Inc for instructions regarding replacement or return.

The recalled product

Product
BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017
Manufacturer
Biomerieux Inc
Hazard
  • temperature-excursion
  • product-performance

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 03573026228255
  • Batch Numbers: 7240

Distribution

Distributed nationwide across the United States.