Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2437-2018 — Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971

U.S. FDA — Device Enforcement · United States · 2018-03-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2437-2018
Date of alert
2018-03-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10469971
Reported risk: The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.