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

Recall Z-2088-2014 — Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

U.S. FDA — Device Enforcement · United States · 2014-06-20 · 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-2088-2014
Date of alert
2014-06-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ITC-Nexus Dx
Product category
device
Product type
Devices
Reported risk: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
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.

Related

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.