BioMerieux SA: Medical Device Recall in 2017 - (Recall #: Z-2126-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 1, 2017

Date Posted: May 31, 2017

Recall Number: Z-2126-2017

Event ID: 77150

Reason for Recall:

Potential performance issue on strain categorization.

Status: Terminated

Product Quantity: 4656 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated