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

Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin s — recall Z-0937-2014

U.S. FDA — Device Enforcement · United States · 2013-12-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0937-2014
Date of alert: 2013-12-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ITC-Nexus Dx
Product category: device
Product type: Devices

Reported risk: ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

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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