Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may provide false susceptible results for antibiotics, which poses a risk of harm to patients through inappropriate treatment, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests. The recall involves 2,495 units of the product, which is a quantitative technique used for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
The recall is being conducted due to the potential for reporting erroneous results for Piperacillin/Tazobactam, specifically false susceptible results. The affected products are identified by Reference number 521418 and specific lot numbers including 1004398470, 1004276460, 1004180840, 1003980200, 1003699550, 1003416920, 1003105180, 1002995820, 1002482640, 1002375410, 1002276210, and 1002092270.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and laboratories should check their inventory for the specific lot numbers listed and stop using the affected products.
The recalled product
- Product
- Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
- Manufacturer
- Biomerieux
- Affected units
- 2,495
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 (12)
- Ref. 521418
- Lot numbers: 1004398470
- 1004276460
- 1004180840
- 1003980200
- 1003699550
- 1003416920
- 1003105180
- 1002995820
- 1002482640
- 1002375410
- 1002276210 and 1002092270.
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
Same manufacturer · Biomerieux
See all →- SevereBiomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
- CriticalBiomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
FDA (Devices) · 2015-12-30
- ModerateBiomerieux Recalls Etest Piperacillin/Tazobactam Tests Due to False Results
FDA (Devices) · 2015-12-30
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
FDA (Devices) · 2014-11-26
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
FDA (Devices) · 2014-11-26
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11