The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0234-2015·Announced 2014-11-26

Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date

Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration instead of the correct 2-year period.

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.

Plain-English summary

Biomerieux is recalling 652 units of Etest Ceftaroline (CPT32) US B30 antimicrobial susceptibility testing devices. The recall is due to a labeling error where the expiration date is printed as 5 years instead of the correct 2 years. The affected devices are identified by Ref #537540, Lot #1003301830, and have a right-side expiration date of 30-APR-2016.

The devices were distributed nationwide in the United States, including DC and 29 states, as well as in 21 countries worldwide. The Etest system is a quantitative technique used to determine the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should stop using the affected devices and contact Biomerieux for instructions on return or replacement.

The recalled product

Product
Etest¿ Ceftaroline (CPT32) US B30. 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 — Laboratory Diagnostic
Hazard
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 #537540
  • Lot #1003301830
  • Right Expiry date: 30-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 →

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