Etest PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest is a quantitative technique for determining the antimicrobial
FDA device recall Z-0441-2016 · posted 2015-12-23 · Terminated
Recall details
- Recalling firm
- Biomerieux
- Reason for recall
- Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- 2495 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,
- Date initiated
- 2015-11-19
- Date posted
- 2015-12-23
- Date terminated
- 2017-06-19
- Location
- Letoile, France
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIPERACILIN TAZOBACTAM 4 UG (K953223) | Ab Biodisk | 1995-08-15 |