Recall Z-2225-2021 — MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
U.S. FDA — Device Enforcement · France · 2021-06-22 · Class II
⚙AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Reported risk: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
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.