—#163468

Product

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.

FDA product code: JWY — Manual Antimicrobial Susceptibility Test Systems
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot Number 1005986140, Expiration date April 1, 2018

Why it was recalled

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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Beckman Coulter sent an Urgent Medical Device Recall letter dated March 16, 2018. Please discontinue use and discard any remaining inventory of the broth lot listed above. You should retain your inventory of other lot numbers of this broth as they are not impacted by this issue. Follow the guidance in the Broth Preparation section of the panel procedural and QC manual. Beckman Coulter recommends discussing the content of this letter with your medical director regarding the need to review previous test results, conduct patient follow-up, and/or repeat testing by another lot of this broth if the isolates are still available. For further questions, please call (469) 961-4941.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2018-03-26
Posted by FDA: 2018-10-02
Terminated: 2018-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163468. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.