Agency classClass IOur severity:Severe FDA (Devices)·Z-0439-2016·Announced 2015-12-30

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.

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 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
Hazard: mis-labeling
diagnostic-error
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

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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 →

Same manufacturer · Biomerieux

See all →

Severe
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC 256 Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
Critical
Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results
FDA (Devices) · 2015-12-30
Severe
Biomerieux Recalls Etest PIP/TAZO/CON-4 PTC Antimicrobial Susceptibility Tests
FDA (Devices) · 2015-12-30
Low
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
FDA (Devices) · 2014-11-26
Low
Biomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
FDA (Devices) · 2014-11-26

Same hazard · mis labeling