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

Recall Z-0086-2014 — HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low

U.S. FDA — Device Enforcement · Sweden · 2013-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0086-2014
Date of alert: 2013-07-16
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: HemoCue AB
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 13028141302815

Reported risk: HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Albumin Microcuvettes single pack pouches.

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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