Agency classClass IIIOur severity:Low FDA (Devices)·Z-0231-2015·Announced 2014-11-26

Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date

Biomerieux is recalling 652 Etest Ceftaroline devices because the labels list a 5-year expiration instead of 2 years.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a labeling error regarding expiration dates, which falls under the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Biomerieux is recalling 652 units of Etest Ceftaroline (CPT32) WWB100 devices. These devices are used for antimicrobial susceptibility testing of Gram-negative and Gram-positive aerobic bacteria. The recall is limited to devices with Reference #537508, Lot #1003160510, and an expiration date of 27-APR-2016.

The recall was initiated because the product labeling displays an incorrect expiration date of 5 years instead of the correct 2-year duration. This labeling error could affect the reliability of the test results if the devices are used beyond their intended shelf life.

The affected devices were distributed worldwide, including nationwide in the United States and in various international markets. Users of these devices should stop using the affected lots and contact Biomerieux for further instructions or a replacement.

The recalled product

Product: Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
Manufacturer: Biomerieux
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 652

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)

Ref #537508
Lot #1003160510
Right Expiry date: 27-APR-2016

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Biomerieux 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 5 products in this recall →

Same manufacturer · Biomerieux

See all →

Severe
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
Severe
Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results
FDA (Devices) · 2015-12-30
Critical
Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
FDA (Devices) · 2015-12-30
Severe
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
Low
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
FDA (Devices) · 2014-11-26

Same hazard · mis labeling