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Recall, Recall, Recall

Another medical device with buggy untested software gets recalled.

Ortho Vision Analyzer

The FDA need to be checking more thoroughly on the credentials of people who write this kind of software. Our health is at stake and this latest recall is due to a basic software error that could have been tested easily – but the manufacturers decided to go the route of placing “happy-path agile testers” onto the team instead.

The product was delivered to market almost two years late, far over-budget, failed to meet some of the fundamental customer requirements, and required key hardware components to be permanently disabled due to unimplemented software controls. A typical Agile delivery.

This would be of no concern if the product was some throw-away ad-funded smartphone app, but it needs to concern us all when our health is being put at risk by the Agile mythology.

This is not the first time this instrument has been recalled either. This is just the latest in a long and sorry list of recalls and defects that have manifested themselves since the first week this instrument was released to market in 2015. These recalls and field safety notices, that we have curated as links below, are the inevitable result of trying to do software on the cheap and allowing research and development within the organisation to be taken over by self-serving out-sourcers and inexperienced temps.

We have the following recommendations which the OEM manufacturer of this low-quality instrument would do well to follow:

  1. Review your hiring policy
  2. Engage independent V&V testers
  3. In-source lifecycle support
  4. Do not allow your external developers to install TFS and their own Operating System builds onto your development hardware outside of strict security control – they can steal your passwords that way, among other things.
  5. Immediately terminate the contracts of and consider legal action against any outsourcers who have in any way adulterated your formal test reports (you may contact us in confidence for specific issue numbers and screenshots that we have obtained).
  6. Search your test documentation for the phrase “system doesn’t take forever” and ask the persons who signed-off on this joke of a test case if they’ve ever heard of The Halting Problem.

Ortho Vision Analyzer Recalls and Urgent Safety Warnings

November 2016 – Inappropriate incubation times in the reaction chamber
February 2016 – Reuse of contanimated dilution wells and patient samples
December 2015 – Insufficent saline not detected by software
April 2015 – Incorrect Patient names allocated to blood tests, cross-contamination of liquids, failure to detect incorrect cleaning agents, and inoperability after routine maintenance

All of them due to low-quality buggy Agile software.

Perhaps this instrument should be taken off the market permanently? Before patients are harmed.


Why You Should Avoid Agile Testing
The Field Safety-Notice
Share your concerns with the FDA