Z-2095-2017 Class II Terminated
FDA device recall Z-2095-2017 was initiated by BioMerieux SA on April 25, 2017 and is designated Class II. Reason for recall: False susceptible results The recall status is terminated (terminated February 24, 2022). Affected quantity: 3,238 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 25, 2017
- Termination Date
- February 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,238 units
Product Description
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)
Reason for Recall
False susceptible results
Distribution Pattern
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
Code Information
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