MAUDE Adverse Event Report: HALOTECH, SRL. / HALOTECH DNA SL HALOTECH G2 KIT; SEMEN ANALYSIS DEVICE

Model Number HT-HSG2

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2020

Event Type  malfunction  

Event Description

Incorrect fertility tmt; not an incident but a violation: (b)(4), is the importer of the halotech line of sperm testing kits and stains which are widely distributed in the us with marketing claims regarding dna fragmentation that have never been validated in human clinical trials and are not reviewed by the fda as a diagnostic test.The safety and efficacy as well as thermal stability of the tests are unknown, yet these tests are marketed widely to the ivf and art communities of healthcare professionals.False or inaccurate readings may lead embryologists and andrologists to prescribe a program of treatment inappropriate for couples seeking to achieve pregnancy.The fda is urged to cease the importation of the halotech g2 kit and the several variants now imported by (b)(4).Dna fragmentation is an indicator of damage caused by oxidative stress to sperm.The fda has not reviewed the halotech line for any efficacy in diagnosis.Fda safety report id# (b)(4).

• Brand Name: HALOTECH G2 KIT
• Type of Device: SEMEN ANALYSIS DEVICE
• Manufacturer (Section D): HALOTECH, SRL. / HALOTECH DNA SL; c/ faraday 7 ; parque científico de madrid; madrid espana 28049 ; SP 28049
• MDR Report Key: 10553331
• MDR Text Key: 207900308
• Report Number: MW5096746
• Device Sequence Number: 1
• Product Code: POV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HT-HSG2
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other