HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 2
FDA device recall Z-0873-2015 · posted 2014-12-24 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag
- Action taken
- The consignees will be notified by a Field Safety Notice. Distributors will be instructed to forward the Field Safety Notice to their end customers and to secure that verification forms will be filled-out by end customers and returned to HemoCue.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 3,712,900 microcuvettes
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Austria, AUSTRALIA, SWITZERLAND, COTE D'IVOIRE, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, FINLAND, FRANCE, UNITED KINGDOM, GEORGIA,
- Date initiated
- 2014-10-20
- Date posted
- 2014-12-24
- Date terminated
- 2015-10-02
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935) | Hemocue, Inc. | 2002-04-03 |