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

Recall Z-2409-2012 — ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use

U.S. FDA — Device Enforcement · United States · 2012-08-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2409-2012
Date of alert: 2012-08-07
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00649625

Reported risk: ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

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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