PRODUCT SAFETY · DOCUMENTATION
Product Compliance and Incident Reporting
Use this page to request product-specific compliance documentation or report a quality concern, adverse event or suspected serious incident involving a product supplied by Testora.
Last updated: 21 August 2026 · Version 1.0 draft
On this page
- 1. Product-specific regulatory information
- 2. Request documentation
- 3. Report a product quality complaint
- 4. Report an adverse event or suspected serious incident
- 5. Information to include
- 6. Preserve the evidence
- 7. What happens after a report
- 8. Recalls and field safety information
- 9. Privacy
- 10. General enquiries
Key point
If someone may need urgent medical assistance, contact the local emergency services or an appropriate healthcare professional immediately. This reporting channel is not an emergency or medical-advice service.
Report a product complaint or incident
For urgent product-safety matters, clearly identify the product and write URGENT PRODUCT INCIDENT in the subject line. Do not include directly identifying patient information in ordinary email.
1. Product-specific regulatory information
Regulatory status, intended purpose, user category, manufacturer, authorised representative, conformity assessment and applicable documentation vary by product. Do not assume that a statement concerning one product applies to the full catalogue. The product labelling and current instructions for use are the primary product-specific information.
2. Request documentation
To request an available instruction for use, declaration of conformity or other product-specific documentation, email support@testora.eu. State your company, country, product name, catalogue number, manufacturer and batch or lot number where available, and identify the document and language required.
3. Report a product quality complaint
Report incorrect labelling, packaging failure, missing components, suspected contamination, unexpected performance, false result concerns, damage, storage deviation or other quality issues promptly. Stop use and quarantine the affected units if continued use may create a risk or compromise an investigation.
4. Report an adverse event or suspected serious incident
Send the report promptly to support@testora.eu with the subject line URGENT PRODUCT INCIDENT. Where required by applicable law or instructions, also report to the competent authority or healthcare channel in the country where the event occurred. Reporting to Testora does not replace a reporter’s own legal or professional reporting duties.
5. Information to include
Provide, where available: reporter name and professional contact details; organisation and country; product and manufacturer; catalogue number; UDI where present; batch or lot number; expiry date; date and location of the event; number of affected units; a factual description; known consequences; actions already taken; photographs; and whether the product and packaging are available. Do not include patient names or unnecessary health information. Use a coded reference where possible.
6. Preserve the evidence
Do not discard, alter, clean, open further, return or send a suspected product unless necessary for immediate safety or instructed by Testora or the relevant responsible operator. Preserve the product, packaging, labels, instructions, related devices and storage or distribution records in a secure quarantine.
7. What happens after a report
Testora will acknowledge the report, request missing information where needed, record the complaint and route it to the relevant manufacturer, authorised representative, importer or other responsible party as appropriate. Testora may provide quarantine, return, replacement, recall or safety instructions. The reporting organisation should maintain contact and promptly provide follow-up information.
8. Recalls and field safety information
Customers must act promptly on recall, field safety notice or corrective-action instructions, identify affected stock and recipients, stop supply or use where instructed, preserve traceability and confirm the quantities quarantined, returned, corrected or destroyed.
9. Privacy
Information in a complaint or incident report is processed for product quality, safety, traceability, legal and regulatory purposes. It may be shared with manufacturers, authorised representatives, importers, competent authorities, insurers, laboratories and advisers where necessary. See the Privacy Policy. Avoid unnecessary patient-identifying information.
10. General enquiries
For non-urgent compliance questions, contact support@testora.eu. Include enough product information to allow us to identify the correct documentation and responsible operator.