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Terminated

HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

FDA Recall Z-2190-2013 · Posted 2013-09-11

Recalling FirmHemoCue AB
Recall StatusTerminated
Product CodeCGA
Date Initiated2013-07-15
Date Terminated2014-09-02
Product Quantity22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US

Reason for Recall

During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

Firm Action

HemoCue sent an Urgent Field Safety Notice dated July 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine any affected product and Return the Field Safety Notice Verification Form to e-mail: [email protected] or fax 562-668-5794 Customers would be contacted to coordinate return and replacement of the affected microcuvettes. Customers with questions were instructed to call 800-426-7256. For questions regarding this recall call 440-925-3485.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIAN FEDERATION, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, VIET NAM & YEMEN. .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706Hemocue, Inc. · 2002-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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