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Recall Observatory FDA recall evidence

Device product

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)

Z-2095-2017

April 25, 2017

Class II

Product summary

Firm
BioMerieux SA
Event
Event 76983
Status
Terminated
Classification
Class II
Quantity
3,238 units
Official record key
device-enforcement:Z-2095-2017

Official wording

Reason: False susceptible results

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    False susceptible results