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

Catalog Number	00009800127
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
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 -244
• Manufacturer (Section G): Biokit S.A.; av. can montcau, 7; lliçà d'amunt; barcelona, 08186 ; SP 08186
• Manufacturer Contact: keith kelly ; 180 hartwell road; bedford, MA 01730--244
• MDR Report Key: 50859735
• Report Number: 1217183-2026-00028
• Device Sequence Number: 21316200
• Product Code: LCO
• UDI-Device Identifier: 08426951126545
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 00009800127
• Device Lot Number: B40005
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2026-009-R
• Patient Sequence Number: 1
• Patient Sex: Unknown