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

Recall Z-1233-2020 — Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

U.S. FDA — Device Enforcement · United States · 2019-12-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1233-2020
Date of alert
2019-12-18
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)
00842768036262
Reported risk: There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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