BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Numbe

FDA device recall Z-1804-2018 · posted 2018-10-02 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

JWY

Quantity affected

523 boxes

Distribution

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

Date initiated

2018-03-26

Date posted

2018-10-02

Date terminated

2018-12-19

Location

Brea, CA