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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

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BIO-RAD LABORATORIES, INC. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) Back to Search Results
Model Number 27104
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2020
Event Type  malfunction  
Manufacturer Narrative
The instruction for use provided by bio-rad for testing the liquichek cardiac markers plus control lt indicated the product contains 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 for (b)(6) surface (b)(6), antibody to (b)(6), and antibody to (b)(6) 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.
 
Event Description
On (b)(6) 2020, a medical technologist from (b)(6) lab called bio-rad qsd technical support to report a potential adverse event that occurred with an employee at their facility. The employee was opening a vial of liquichek cardiac markers plus control lt, level 1a, lot # 23694 and the contents splashed onto her right eye while not wearing safety goggles. The employee washed and flushed her eyes and also washed her face. The incident was reported to facilities health and the employee was seen by a doctor. No medical tests were done. The employee had all the screenings done at pre-employment time. The employee and facility have access to product's package insert, msds and coa.
 
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Brand NameLIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A
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 Key9745217
MDR Text Key221576364
Report Number2016706-2020-00001
Device Sequence Number1
Product Code JJY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050537
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 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date11/30/2020
Device Model Number27104
Device Catalogue Number27104
Device Lot Number23694
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 Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2017
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: 02/24/2020 Patient Sequence Number: 1
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