Beckman Coulter Inc.: Medical Device Recall in 2018 - (Recall #: Z-1804-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

Product Classification:

Class II

Date Initiated: March 26, 2018

Date Posted: May 23, 2018

Recall Number: Z-1804-2018

Event ID: 79800

Reason for Recall:

Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism Streptococcus pneumoniae (ATCC 49619) during quality control (QC) testing on MICroSTREP plus(R) Panel Type 1 hydrated with Mueller-Hinton Broth with 3% lysed horse blood part number B1015-25 lot number 1005986140.

Status: Terminated

Product Quantity: 523 boxes

Code Information:

Lot Number 1005986140, Expiration date April 1, 2018

Distribution Pattern:

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Kuwait, South Korea and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated