Agency classClass IOur severity:Severe FDA (Devices)·Z-0440-2016·Announced 2015-12-30

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.

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 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
Category: Medical Device — In Vitro Diagnostics
Hazard: erroneous-results
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

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 Piperacillin/Tazobactam Tests Due to False Results
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 · erroneous results