Agency classClass IIOur severity:High FDA (Devices)·Z-0265-2018·Announced 2017-12-27

BioMerieux Recalls ETEST OXACILLIN Strips Due to Quality Control Failures

BioMerieux SA is recalling ETEST OXACILLIN OX 256 WW F100 in vitro diagnostic 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 is classified as FDA Class II. The hazard involves potential false resistant results in diagnostic testing, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

BioMerieux SA is recalling 1,585 units of ETEST OXACILLIN OX 256 WW F100, an in vitro diagnostic product used to determine the antimicrobial susceptibility of bacteria species. The recall is due to reported quality control failures where the Minimum Inhibitory Concentration (MIC) for the S. aureus ATCC 29213 strain was out of range (high).

The affected product is identified by Reference 520518 and includes lot numbers 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270, and 1005366110. The product was distributed nationwide in the United States and to numerous countries worldwide, including Algeria, Austria, Australia, Canada, France, Germany, India, Japan, Mexico, the United Kingdom, and others.

The product behavior associated with these quality control failures could lead to false resistant results in antimicrobial susceptibility testing. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.

The recalled product

Product: ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Manufacturer: BioMerieux SA
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
quality-control-failure
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 (7)

REF: 520518
Lot numbers: 1003055340
1003315740
1004070580
1004319590
1004818850
1004890270 and 1005366110.

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.

See all 2 products in this recall →

Same manufacturer · BioMerieux SA

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Same hazard · mis labeling