MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK IMMUNOLOGY CONTROL LEVEL 3; JJY

Catalog Number	596
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a laboratory technician at (b)(6), located at (b)(6), reported an eye splash incident involving themselves.The technician was not wearing safety glasses while discarding a qc sample cup into a nearly full biohazard bin.When the cup, containing the liquichek immunology control qc sample, bounced back after being tossed, liquid sprayed into the technician's left eye.The technician immediately rinsed their eye at the eye wash station.Afterward, they contacted the hospital and were prescribed antiviral eye drops over the phone.No harm or injury resulted from this event.The employee and facility had product's instructions for use (ifu) and safety data sheet (sds) and were provided instructions over the phone of how to obtain the certificate of analysis.
Additional Manufacturer Narrative
Instruction for use (ifu) provided by bio-rad for testing liquichek immunology control indicates the product contains human source materials and should be considered as potentially infectious and handled with good laboratory practice.Each human donor unit used to manufacture this product was tested as required by fda accepted methods.Test 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 test.In accordance with good laboratory practice, all human source materials should be considered potentially infectious and handled with the same precautions used with patient specimens.The ifu of liquichek immunology control indicate that caution should be used when handling this product to prevent splashing and instructs the user to wear appropriate eye/face protection when using this product to protect from splashes.

• Brand Name: LIQUICHEK IMMUNOLOGY CONTROL LEVEL 3
• Common Device Name: JJY
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer Contact: gabriela mclellan ; 9500 jeronimo road; irvine, CA 92618-2017 ; 9495981200
• MDR Report Key: 21691818
• Report Number: 2016706-2025-00010
• Device Sequence Number: 8668310
• Product Code: JJY
• UDI-Device Identifier: 00847661001201
• UDI-Public: 00847661001201
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 596
• Device Lot Number: 85723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown