BioMerieux Recalls ETEST Oxacillin Strips Due to Quality Control Failures
BioMerieux SA is recalling ETEST Oxacillin strips due to quality control failures that may cause false resistant results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where the defect could lead to incorrect clinical results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
BioMerieux SA is recalling 1,585 units of ETEST OXACILLIN OX 256 US F100, an in vitro diagnostic used to determine the antimicrobial susceptibility of bacteria species. The recall is due to quality control failures where the Minimum Inhibitory Concentration (MIC) for the S. aureus ATCC 29213 strain was out of range (high).
The product behavior could lead to false resistant results, which may impact clinical decision-making regarding antibiotic treatment. The affected product is identified by Reference 520558 and includes lot numbers 1003059010, 1003315830, 1004071250, 1004818860, and 1004890400.
The product was distributed worldwide, including the United States and numerous international locations. Healthcare facilities and laboratories should stop using the affected product and contact BioMerieux SA for further instructions.
The recalled product
- Product
- ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
- Manufacturer
- BioMerieux SA
- Affected units
- 1,585
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 (5)
- REF: 520558
- Lot numbers: 1003059010
- 1003315830
- 1004071250
- 1004818860 and 1004890400.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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