Product Wiki · Recalls · Health Canada — Medical Devices

BD MAX SYSTEM SOFTWARE V4.44A(2015-07-30) — recall 53645

Health Canada — Medical Devices · Canada · 2015-08-24 · Type III

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
53645
Date of alert
2015-08-24
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: BD Max System Software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (OSR) customers utilizing user defined protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause OSR customer system to incorrectly switch the columns of the truth table on the user's display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bd-max-system-software-v444a20

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.