Biomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results
Biomerieux is recalling Etest Piperacillin/Tazobactam tests because they may report false susceptible results for bacteria.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the hazard is a diagnostic error (false susceptible results) rather than a direct physical injury or contamination. Per the rubric, this falls under moderate risk as it involves a potential for incorrect clinical decisions without reported immediate physical harm or fatalities.
Plain-English summary
Biomerieux is recalling 5,458 units of Etest Piperacillin/Tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests. The recall is due to the potential for the tests to report erroneous results, specifically false susceptible results, for Piperacillin/Tazobactam.
The affected products are identified by Ref. 412434 and include lot numbers 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490, and 1001936360. These tests are a quantitative technique used for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
The products were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and laboratories should stop using the affected lots and contact Biomerieux for further instructions.
The recalled product
- Product
- Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
- Manufacturer
- Biomerieux
- Category
- Medical Device — Laboratory Test
- Affected units
- 5,458
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 (10)
- Ref. 412434
- Lot numbers: 1004331500
- 1004271120
- 1004178060
- 1003977300
- 1003697470
- 1003415090
- 1003276060
- 1003069230
- 1002488490 and 1001936360.
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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