FDA Medical Device Recalls (openFDA)
Biomerieux: 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.
- Recall number
- Z-0440-2016
- Recalling firm
- Biomerieux
- 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.
- Status
- Terminated
- Initiated
- 2015-11-19
- Posted
- 2015-12-23
- Terminated
- 2017-06-19
- Reason
- Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
- Root cause
- Process change control
- Action
- Consignees (Subsidiaries and Distributors) of bioMrieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on November 24th, 2015. Additionally, the bioMrieux United States subsidiary notified US consignees (distributors/end-users) of the FSCA notification via FedEx on December 2nd, 2015.
- Quantity
- 1216 units
- Distribution
- Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
- Lot, serial or model codes
- Ref. 412433, Lot numbers: 1004394540, 1003903640, 1003558430, 1003069250, 1002372580 and 1001938220
- 510(k) numbers
- ["K953223"]
- PMA numbers
- not on file
- Product code
- JWY
- Firm FEI
- 1000611339
- Firm city
- Letoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28