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

IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treat — recall Z-0212-2015

U.S. FDA — Device Enforcement · United States · 2014-10-20 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0212-2015
Date of alert: 2014-10-20
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): 10385383

Reported risk: A typographical error regarding the expiration date was identified in the control module instructions for use.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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