Recall Z-1233-2010 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Vital Diagnostics, Inc.
Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
| Date | Apr 6, 2010 (initiated Dec 4, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 871 Kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040273 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL Bio-Rad Laboratories, Inc., Mar 4, 2004 |