FDAFDA · Food and drugs·Recall number Z-2095-2017
ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
Published May 24, 2017 · Recall initiated: April 25, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
False susceptible results
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioMerieux SA
- Distributor
- NATIONWIDE DISTRIBUTION TO AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, M, MA, MD, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY
- Lot
- REF 531640 Lot Number - 1003149850, 1003157690, 1003585350, 1003732380, 1003910410, 1004142070, 1004113370, 1004325260, 1004382730, 1004482780, 1004785720, 1004890160, 1005134380, 1005134390, 1005357180, 1005442470 --- REF 531600 - was not distributed in the United States
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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