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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES LIQUICHEK TUMOR MARKER CONTROL; MULTI-ANALYTE CONTROL, ALL KINDS (ASSAYED ) JJY
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BIO-RAD LABORATORIES LIQUICHEK TUMOR MARKER CONTROL; MULTI-ANALYTE CONTROL, ALL KINDS (ASSAYED ) JJY Back to Search Results
Lot Number 23591
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2018, bio-rad qsd technical support received a call from bio-rad (b)(4) reporting a potential adverse event.Dr.(b)(6) at hospital (b)(6) reported that mrs.(b)(6), a laboratory technician dropped liquichek tumor marker control lot #23951 on the floor and it splashed into her eye.
 
Event Description
On (b)(6) 2018, bio-rad qsd technical support received a call from bio-rad (b)(4) reporting a potential adverse event.Dr.(b)(6) at hospital (b)(6) reported that mrs.(b)(6), a laboratory technician dropped liquichek tumor marker control lot #23951 on the floor and it splashed into her eye.
 
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Brand Name
LIQUICHEK TUMOR MARKER CONTROL
Type of Device
MULTI-ANALYTE CONTROL, ALL KINDS (ASSAYED ) JJY
Manufacturer (Section D)
BIO-RAD LABORATORIES
9500 jeronimo road
irvine CA 92618 2017
Manufacturer (Section G)
BIO-RAD LABORATORIES
9500
jeronimo road
irvine CA 92618 2017
Manufacturer Contact
azar khatibi
9500
jeronimo road
irvine, CA 92618-2017
9495981210
MDR Report Key8089923
MDR Text Key129321897
Report Number2016706-2018-00006
Device Sequence Number1
Product Code JJY
UDI-Device Identifier00847661001447
UDI-Public00847661001447
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K071675
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date11/30/2019
Device Lot Number23591
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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