unknown serial number

The alert message may indicate an attempt at counterfeiting and is automatically forwarded to the competent authorities.

Description and cause:

The recorded serial number could not be found. Possible reasons:

  • The serial number was not uploaded by the manufacturer. It is probably an isolated case (blind passenger).
  • The serial number was transferred incorrectly (e.g. incorrect entry in manual mode).
  • The pack is a counterfeit.

Handling instructions:

The pack must be separated and must not be brought to market until the cause of the alert has been determined.

Procedures for the scanning staff: ​

  1. are there any (manual) input errors?
  2. is the scanner working properly?
  3. are other packs of the delivery or the storage unit also affected?

Procedures for the responsible person:​

  1. photograph the 2D matrix code and the data in human readable form
  2. follow the rules of your NMVO for handling suspicious cases.

Further use of the pack ​

ATTENTION! A pack with a code error is not marketable. Any other facility in the pharmaceutical supply chain will receive the same alert message and reject your supply.

Special case return: If the pack is returned, the responsible person can specify simplified quarantine rules, for example, release the pack for destruction immediately. The lack of marketability may be the reason for returning the pack.

Special case of freshly produced medicine: It cannot be ruled out that packs are already delivered to the 3PL although the associated data have not yet been uploaded to the verification system. Contact the manufacturer to clarify such cases directly.

Ordering new Aggregation Codes

Please allow up to 24 hours for your order to be processed. We will then send the newly generated Aggregation Codes as a PDF to the email address provided here.

Please enter the number of Aggregation Codes you required:

Request a Replacement Device

Is your FMD Speed Scanner no longer working? To ensure you can continue working without interruption, we will send you a replacement device as quickly as possible. At the same time, you will receive a return label for sending back your defective device.

You will receive the replacement unit regardless of whether your warranty is still valid.

Terms of service

Support for counterfeit alerts

Do you suspect counterfeiting? Our medAspis Alert Team will assist you with the process. We are also happy to assist you with unclear error messages or unfamiliar situations.

Describe the incident using the report form. If needed, you can upload up to three photos. We will contact you as soon as possible and support you with the next steps.

Please enter an alert category:
Photos of packs, the Control Panel or the display of the FMD Speed Scanner
(max. 3 photos)

Compliance Check-up: FMD under review

Companies in the pharmaceutical industry are validated and meet strict quality requirements. Nevertheless, there is still a significant compliance risk with FMD.

Suspected falsification cases may not be handled and documented in a GxP-compliant manner.

With our free, anonymous and non-binding Compliance Check-up, we analyse and assess your company’s critical FMD error messages.

Review compliance

Based on your existing FMD audit trails, we analyse among other things:

The analysis is performed entirely within your data system. No data is transmitted to medAspis. All evaluations remain anonymous.

Request Compliance Check-up

Is there a specific reason for the Compliance Check-up?

Error messages

Download the error messages directly to your computer in your local language.

Error messages

Can’t find your language? As soon as you become a customer, we’ll of course provide the error messages in your local language. Promise.

Systematic Validation

medAspis stands for proven quality and traceable processes. Lean FMD provides the necessary framework for this.

Validated and Documented

Lean FMD is validated in accordance with EU-GMP Annex 15. medAspis operates a Quality Management System in accordance with ISO 9001 and supports you with validation and the required documentation.

Validation toolkit

With the Validation Toolkit, you receive the documentation for the validation of Lean FMD. This enables you to carry out the necessary validation steps in a structured and traceable manner.

Download an excerpt from the Validation Toolkit to get a first impression of the structure and process of validation.

The complete toolkit contains all the necessary documents for validating Lean FMD.