MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL SYNTHASIL; ACTIVATED PARTIAL THROMBOPLASTIN

Catalog Number	00020006800
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/21/2025, instrumentation laboratory received a customer complaint regarding microbacterial contamination with vials of hemosil synthasil lot n1136730.The customer randomly inspected 15 out of 75 vial boxes and determined that 1 or 2 vials in each box were contaminated.There was no negative patient impact reported.
Additional Manufacturer Narrative
Multiple customer complaints have been received reporting visible mold contamination in some vials of hemosil synthasil lot no.N1136730, causing quality control (qc) materials to recover high, outside the labeled acceptance ranges.Based on the initial investigation, the issue was assessed as presenting negligible safety risk, and therefore neither mdr reporting nor a field action was required at that time.However, recent testing suggests that patient results may be affected when contaminated vials are used.Based on the additional information and the reassessed (rescored) clinical risk, a class ii fda-reportable field action is being initiated on december 11, 2025, under internal id no.(b)(4), instructing customers to destroy any remaining inventory of lot n1136730.In addition, the six (6) associated complaints are each being filed as separate mdrs using an awareness date of december 9, 2025 (last signature on the risk assessment).All six complaints involved qc out of range, with no impact to reported patient results.No mdr follow-up reports will be submitted, as any corrective action activities will be tracked through the associated recall.This recall will be reported to fda oii/omdrhi, northeast division, and tracked to a 100% effectiveness check in the united states.

• Brand Name: HEMOSIL SYNTHASIL
• Common Device Name: ACTIVATED PARTIAL THROMBOPLASTIN
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730 2443
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 526 route 303; orangeburg NY 10962
• Manufacturer Contact: keith kelly ; 180 hartwell road; bedford, MA 01730-2443
• MDR Report Key: 23783078
• Report Number: 1217183-2025-00052
• Device Sequence Number: 10144177
• Product Code: GFO
• UDI-Device Identifier: 08426950078920
• UDI-Public: (01)08426950078920(11)240101(17)251231(10)N1136730
• Combination Product (Y/N): N
• Initial Reporter Country: MC
• PMA/510(K) Number: K060688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 12/11/2025

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: 12/31/2025
• Device Catalogue Number: 00020006800
• Device Lot Number: N1136730
• 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: 03/21/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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: TBD
• Patient Sequence Number: 1
• Patient Sex: Unknown