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

Recall Z-2430-2020 — ADVIA Chemistry Calibrator

U.S. FDA — Device Enforcement · United States · 2020-06-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2430-2020
Date of alert
2020-06-05
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)
00630414223414
Reported risk: Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

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