Z-1804-2018Class II

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

Name: Z-1804-2018 BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood...
Creator: Beckman Coulter Inc.
Published: 2018-03-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-03-26 / Terminated

FDA source

Beckman Coulter Inc. began a recall of BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth... on 2018-03-26. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1804-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Posted: 2018-10-02
Terminated: 2018-12-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
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.
FDA 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 broth if the isolates are still available. For further questions, please call (469) 961-4941.
Quantity in commerce: 523 boxes
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Kuwait, South Korea and Saudi Arabia.
Product codes and lots: Lot Number 1005986140, Expiration date April 1, 2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1804-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1804-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11

Product code JWY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)