Beckman Coulter Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
Catalog Number: C78500 UDI-DI code: 15099590754013 Serial Numbers: BH44060, BJ09004, BJ14015, BJ09010, BJ13012, BJ14014, BJ13011, BJ14017, BJ13013, BJ09003, BJ09008, BJ09009, BH39057, BH44059, BJ14016, BJ05002, BJ17020, BJ17021, BH26031, BJ19024, BJ09005, BJ09006, BJ09007, BJ19022, BJ19023
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →