Recall Z-0824-2012 ยท CGA Glucose Oxidase, Glucose
Hemo Cue, Inc.
HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been delivered to customers. Still in stock at distributor HemoCue Inc. "" Article not available in US Quantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. The quantitativ
| Date | Jan 20, 2012 (initiated May 30, 2011) |
| Status | Terminated |
| Reason | A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections. |
| Root cause | Packaging process control |
| Action | HemoCue sent a Medical Device Correction Notification letter dated June 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to passed on the notice to all that need to be aware with their organization or to any organization where the affected lot numbers have been distributed. Customers were instructed to sign the Correction Notification Verification form below and return to HemoCue Inc. Customers received the revised package insert with the notification letter. Customers with any |
| Quantity | 13,620 packages |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Czech Republic, Denmark, Slovenia, Norway, Sweden, Switzerland, United Kingdom, Finland, Germany, Netherlands, Poland, Romania, and Tanzania. |
| 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 |