MAUDE Adverse Event Report: Instrumentation Laboratory Co. HemosIL AcuStar HIT-IgG (PF4-H); Platelet Factor 4 Radioimmunoassay

Catalog Number	0009800127
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction

• Brand Name: HemosIL AcuStar HIT-IgG (PF4-H)
• Common Device Name: Platelet Factor 4 Radioimmunoassay
• Manufacturer (Section D): Instrumentation Laboratory Co.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): Instrumentation Laboratory Co.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: keith kelly ; av. can montcau, 7; lliçà d'amunt; barcelona,, MA 08186 ; SP 08186
• MDR Report Key: 50347530
• Report Number: 1217183-2026-00019
• Device Sequence Number: 14962264
• Product Code: LCO
• UDI-Device Identifier: 08426951126545
• UDI-Public: (01)08426951126545(11)260129(17)270116(10)B40005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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 Catalogue Number: 0009800127
• Device Lot Number: B40005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown