The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1527-2017·Announced 2017-03-29

BioMerieux Recalls Etest Benzyl Penicillin Strips Due to Stability Issues

BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging because shelf-life claims are not supported by internal testing.

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 2/5 (Moderate).

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, but the hazard is a documentation/stability issue (unsupported shelf-life claims) rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling or documentation issues.

Plain-English summary

BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging, a quantitative technique used to determine the antimicrobial susceptibility of various bacteria. The recall is due to product stability issues, specifically that the current shelf-life claims for these products are not supported by internal testing.

The affected products include Etest Benzylpenicillin PG 0.016-256 (high) with Reference no. 502558 and Reference no. 502518. Specific lot numbers are listed in the recall documentation. The products were distributed worldwide, including nationwide in the United States and in numerous foreign countries.

Users of these medical devices should stop using the affected lots and contact BioMerieux SA for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae…
Manufacturer
BioMerieux SA
Category
Medical Device — In Vitro Diagnostics
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 (20)

  • Reference no. 502558
  • Lot #1003036730
  • 1003142000
  • 1003191650
  • 1003408580
  • 1004047410
  • 1004139950
  • 1004242300
  • 1004539350
  • 1004783810
  • 1004872380
  • 1004910650 & 1004985540 and Reference no. 502518
  • Lot #1002911350
  • 1002964350
  • 1003012790
  • 1004047370
  • 1004140000
  • 1004244180
  • 1004420440
  • 1004539950

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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