The Recall Desk
ModerateFDA (Devices)·Z-1522-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Cephalothin CE 256 Foam Packaging Due to Stability Issues

BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.

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: The recall is classified as FDA Class II. The hazard is a stability issue where shelf-life claims are unsupported, which is a quality control defect rather than a direct physical or biological hazard like a pathogen or structural failure. No injuries or illnesses are reported.

Plain-English summary

BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging (Reference no. 503558, Lot #1003158260 and Reference no. 503518, Lot #1003161140). The recall is due to product stability issues, specifically that the current shelf-life claims for these ETEST products are not supported by internal testing.

The affected product is a quantitative technique used for determining the antimicrobial susceptibility of various bacteria. The recall involves worldwide distribution, including the United States and numerous foreign countries. No specific number of affected units is stated in the source text.

Consumers and healthcare facilities should stop using the affected lots and contact BioMerieux SA for further instructions or a replacement.

The recalled product

Product
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
Manufacturer
BioMerieux SA
Category
Medical Device — Laboratory Diagnostic
Hazard

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 (3)

  • Reference no. 503558
  • Lot #1003158260 and Reference no. 503518
  • Lot #1003161140.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by BioMerieux SA 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 12 products in this recall →

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