Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the
FDA device recall Z-1233-2010 · posted 2010-04-06 · Terminated
Recall details
- Recalling firm
- Vital Diagnostics, Inc.
- Reason for recall
- Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.
- Action taken
- Customers were mailed copies of Technical Bulletin 8100 and 5024 dated September 30, 2009 which advised of the Alkaline Phosphatase QC value revisions for the Envoy 500 and the ATAC 8000. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJY
- Quantity affected
- 871 Kits
- Distribution
- Nationwide.
- Date initiated
- 2009-12-04
- Date posted
- 2010-04-06
- Date terminated
- 2012-07-25
- Location
- Lincoln, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LYPHOCHEK ASSAYED CHEMISTRY CONTROL (K040273) | Bio-Rad Laboratories, Inc. | 2004-03-04 |