MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS, INC. HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - ACT-LR CUVETTES; HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT

Model Number	JACT-LR
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the returned test cuvettes from the customer showed no other foreign objects were found.Accriva diagnostics has initiated a recall per 21 cfr 806.Accriva has requested all data required for form 3500a, fields for which data were not obtainable or are not applicable are intentionally left blank: a2-a6, b2, b6-b7, d6-d7, d10, f1-f14, g5, h2, h9-h10.
Event or Problem Description
Accriva diagnostics, inc.Has identified that an inadvertent foreign object was included in at least one (1) sealed pouch of hemochron activated clotting time low-range (act-lr) test cuvettes, lot number e5jlr132.The foreign object has sharp edges and could pose a risk of injury for users handling the product if this issue were to re-occur.Currently, there is no indication that any other lots of hemochron test cuvettes are impacted by this issue.To date, no adverse events or injuries have been reported, and only a single customer complaint regarding this issue has been received.

• Brand Name: HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - ACT-LR CUVETTES
• Common Device Name: HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego CA 92121
• Manufacturer (Section G): ACCRIVA DIAGNOSTICS, INC.; 6260 sequence drive; san diego 92121
• Manufacturer Contact: candice cho ; 6260 sequence drive; san diego, CA 92121 ; 8582632300
• MDR Report Key: 23469452
• Report Number: 0002250033-2025-00003
• Device Sequence Number: 9076594
• Product Code: JBP
• UDI-Device Identifier: 10711234103081
• UDI-Public: 10711234103081
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: JACT-LR
• Device Catalogue Number: JACT-LR
• Device Lot Number: E5JLR132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown