BECKMAN COULTER MicroScan MICroSTREP Plus Panel — Class II medical device recall Z-1804-2018
Terminated recall by Beckman Coulter Inc., reported 2018-05-23, distributed nationwide. Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimic
| Recall number | Z-1804-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2018-03-26 |
| Classified | 2018-05-11 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2018-12-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR, KW, SA |
| Quantity | 523 boxes |
| Lot numbers | 1005986140 |
| Model numbers | 81015 |
| Expiration dates | 2018-04-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1804-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.