Health Canada — Medical Devices · Canada · 2013-02-04 · Type I
🏛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 →
Archived by the issuing authority — kept for reference
Reported risk: When using the Roche Cobas E411 (RCHCE41I) driver version 8.00.0001 or 8.00.0002, if there is a barcode read error, the current sample may be identified as the last sample ID that was in that rack or disk position potentially causing sample mismatch. If the last sample had any pending tests in the orders database, test selection would be downloaded to the instrument with the incorrect sample ID, and results would be reported on the wrong sample.
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.
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.