Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC antimicrobial susceptibility tests due to the potential for reporting erroneous results, specifically false susceptible results for Piperacillin/Tazobactam.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to erroneous test results.
Plain-English summary
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC antimicrobial susceptibility tests (Ref. 412433) due to the potential for reporting erroneous results. The recall specifically concerns the risk of false susceptible results for Piperacillin/Tazobactam. The affected product is a quantitative technique used for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
The recall involves 1,216 units distributed worldwide, including the United States and numerous international countries. The specific lot numbers affected are 1004394540, 1003903640, 1003558430, 1003069250, 1002372580, and 1001938220. The agency has classified this as a Class I recall.
Healthcare facilities and distributors should stop using the affected lots and contact Biomerieux for further instructions. Users should verify their inventory against the listed lot numbers to ensure they are not using the recalled tests.
The recalled product
- Product
- Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
- Manufacturer
- Biomerieux
- Hazard
- Affected units
- 1,216
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 (6)
- Ref. 412433
- Lot numbers: 1004394540
- 1003903640
- 1003558430
- 1003069250
- 1002372580 and 1001938220
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.
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