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

Recall Z-2643-2014 — ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 an

U.S. FDA — Device Enforcement · United States · 2014-08-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2643-2014
Date of alert: 2014-08-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10491408

Reported risk: The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.

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.

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.

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