HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affe
FDA device recall Z-0824-2012 · posted 2012-01-20 · Terminated
Recall details
- Recalling firm
- Hemo Cue, Inc.
- Reason for recall
- A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.
- Action taken
- 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 questions regarding the Correction Notification could please call (562) 668-5665.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 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 Tanzan
- Date initiated
- 2011-05-30
- Date posted
- 2012-01-20
- Date terminated
- 2012-03-02
- Location
- Cypress, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935) | Hemocue, Inc. | 2002-04-03 |