Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
Biomerieux is recalling 652 Etest Ceftaroline devices because the labeling displays a 5-year expiration period instead of the correct 2-year period.
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 by definition is unlikely to cause adverse health consequences. The issue is a documentation and labeling error regarding the expiration date.
Plain-English summary
Biomerieux is recalling 652 units of Etest Ceftaroline (CPT32) US B30 devices. The recall is due to a labeling error where the expiration date is listed as 5 years instead of the correct 2 years.
The affected devices are identified by Reference #537540, Lot #1003202200, and an expiration date of 27-APR-2016. These devices are used for antimicrobial susceptibility testing of aerobic bacteria.
The products were distributed nationwide in the United States, including DC and specific states, as well as in various international countries. Users should stop using the affected devices and contact Biomerieux for further instructions.
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
- 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 #1003202200
- 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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