FDA Device recall Z-1804-2018
BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan M…
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan M… by Beckman Coulter, citing beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1804-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-26 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot Number 1005986140, Expiration date April 1, 2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1804-2018%22
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