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

Recall Z-0619-2013 — Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are m

U.S. FDA — Device Enforcement · Sweden · 2012-11-07 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0619-2013
Date of alert: 2012-11-07
Country / jurisdiction: Sweden
Risk level: Class III
Risk type: recall
Brand: HemoCue AB
Product category: device
Product type: Devices

Reported risk: Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.

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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