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

Recall Z-1420-2017 — IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of

U.S. FDA — Device Enforcement · United States · 2017-01-04 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1420-2017
Date of alert: 2017-01-04
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): 10381128

Reported risk: DHEA-S causes falsely elevated progesterone results.

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.

Related