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Recall Observatory FDA recall evidence

Device product

Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba

Z-2126-2017

January 01, 2017

Class II

Product summary

Firm
BioMerieux SA
Event
Event 77150
Status
Terminated
Classification
Class II
Quantity
4656 kits
Official record key
device-enforcement:Z-2126-2017

Official wording

Reason: Potential performance issue on strain categorization.

Code information: Ref 412302  1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058  1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030

Distribution pattern: USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential performance issue on strain categorization.