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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK IMMUNOASSAY PLUS CONTROL, TRILEVEL MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

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BIO-RAD LABORATORIES, INC. LIQUICHEK IMMUNOASSAY PLUS CONTROL, TRILEVEL MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) Back to Search Results
Model Number 360
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
Instruction for use (ifu) provided by bio-rad for testing liquichek immunoassay plus control, liquichek cardiac markers plus control lt, and liquid assayed multiqual indicated products contain human source materials and should be considered potentially infectious and handled with the same precautions used with patient specimens in accordance with good laboratory practice. Each human donor unit used to manufacture this product was tested as required by fda accepted methods. Tests results were non-reactive or negative for evidence of infection due to human immunodeficiency virus (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv). This product may also contain other human source materials for which there are no approved tests. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens. Liquichek immunoassay plus control has a hazardous warning contain sodium azide as a preservative. Sodium azide can react with copper, brass, lead, and solder in piping systems to form explosive compounds of lead azide and copper azide.
 
Event Description
On (b)(6) 2020, a laboratory information manager from (b)(6) medical center- (b)(6) called bio-rad qsd technical support to report a potential adverse event that occurred with a technician at their facility. In the facility chemistry lab, the employee removed qc rack from instrument and emptied a rack of qc vials into sink. While dumping, the mixture of qc splashed into the technician's eyes. The technician was not wearing safety glasses, which is a laboratory requirement for ppe in this facility. The following qc products were on the qc rack and plashed in the technician's eyes: liquichek immunoassay plus control: trilevel: lot 41000. Liquichek cardiac markers plus control lt: level 2: lot 23692, level 3: lot 23693, level 1b: lot 23695. Liquid assayed multiqual: level 1: lot 45791, level 3: lot 45793. The employee washed eyes immediately in the emergency eye wash station. The incident was reported to facilities health and the employee was sent to the employee health center for evaluation. No details of the visit to employee health center was provided. It was reported that no additional medical attention was required. The employee and facility was provided with package insert, sds and certificate of analysis for all 8 products that were splashed in the technician's eyes.
 
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Brand NameLIQUICHEK IMMUNOASSAY PLUS CONTROL, TRILEVEL
Type of DeviceMUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
Manufacturer (Section D)
BIO-RAD LABORATORIES, INC.
9500 jeronimo road
irvine, ca
Manufacturer (Section G)
BIO-RAD LABORATORIES, INC.
9500 jeronimo road
irvine, ca
Manufacturer Contact
maria zeballos
9500 jeronimo road
irvine, ca 
9981200136
MDR Report Key9806089
MDR Text Key205535399
Report Number2016706-2020-00002
Device Sequence Number1
Product Code JJY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Model Number360
Device Catalogue Number360
Device Lot Number41000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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