The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1526-2017·Announced 2017-03-29

BioMerieux Recalls ETEST Doripenem Strips Due to Stability Issues

BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.

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 stability/shelf-life issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

BioMerieux SA is recalling specific lots of ETEST Doripenem DOR32 FOAM packaging, a medical device used to determine the antimicrobial susceptibility of various bacteria. The recall is due to product stability issues, as the current shelf-life claims for these products are not supported by internal testing.

The affected products are distributed worldwide, including in the United States and numerous foreign countries. Specific lots involved include Reference no. 535958 (Lot #1004265390 & 1005138210) and Reference no. 535918 (Lot #1003902400, 1004103780, 1004266960, 1004867770). Users should check their inventory for these specific reference and lot numbers.

The recalled product

Product
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and…
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 (6)

  • Reference no. 535958
  • Lot #1004265390 & 1005138210 and Reference no. 535918
  • Lot #1003902400
  • 1004103780
  • 1004266960
  • 1004867770.

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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