Recall Z-2190-2013 ยท CGA Glucose Oxidase, Glucose
HemoCue AB
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
| Date | Sep 11, 2013 (initiated Jul 15, 2013) |
| Status | Terminated |
| Reason | During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. |
| Root cause | Packaging |
| 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: 2013glufsn@hemocue.com 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. |
| Quantity | 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 Hemocue, Inc., Apr 3, 2002 |