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.
What this means for you
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
- 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 #537508
- Lot #1003160510
- Right Expiry date: 27-APR-2016
Distribution
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 →Related recalls
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