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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results."
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
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See all →- SevereBiomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
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- CriticalBiomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
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