LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3 27113

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-18 for LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3 27113 manufactured by Bio-rad Laboratories, Inc..

MAUDE Entry Details

• Report Number: 2016706-2019-00001
• MDR Report Key: 9082451
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-09-18
• Date of Report: 2019-09-18
• Date of Event: 2019-08-21
• Date Mfgr Received: 2019-08-21
• Device Manufacturer Date: 2019-07-31
• Date Added to Maude: 2019-09-18
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. MARIA ZEBALLOS
• Manufacturer Street: 9500 JERONIMO ROAD
• Manufacturer City: IRVINE CA 926182017
• Manufacturer Country: US
• Manufacturer Postal: 926182017
• Manufacturer Phone: 9499981200
• Manufacturer G1: BIO-RAD LABORATORIES, INC.
• Manufacturer Street: 9500 JERONIMO ROAD
• Manufacturer City: IRVINE CA 926182017
• Manufacturer Country: US
• Manufacturer Postal Code: 926182017
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3
• Generic Name: MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Product Code: JJY
• Date Received: 2019-09-18
• Catalog Number: 27113
• Lot Number: 27373
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIO-RAD LABORATORIES, INC.
• Manufacturer Address: 9500 JERONIMO ROAD IRVINE CA 926182017 US 926182017

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-09-18