Recall Z-1804-2018 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Beckman Coulter Inc.
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 g
| Date | Oct 2, 2018 (initiated Mar 26, 2018) |
| Status | Terminated |
| Reason | 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 | Unknown/Undetermined by firm |
| Action | 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 brot |
| Quantity | 523 boxes |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Kuwait, South Korea and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.