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

Recall Z-1540-2018 — Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.

U.S. FDA — Device Enforcement · United States · 2018-01-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1540-2018
Date of alert
2018-01-30
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)
10445160
Reported risk: May produce erroneously low results from specific well sets.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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