Z-1233-2010

Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods...

Name: Z-1233-2010 Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods...
Creator: Vital Diagnostics, Inc.
Published: 2009-12-04
License: https://open.fda.gov/license/

ELITechGroup Inc / initiated 2009-12-04 / Terminated

FDA source

Vital Diagnostics, Inc. began a recall of Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range on 2009-12-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1233-2010
Status: Terminated
Initiated: 2009-12-04
Posted: 2010-04-06
Terminated: 2012-07-25
Recalling firm: ELITechGroup Inc
Product: Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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.
FDA 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 in commerce: 871 Kits
Distribution: Nationwide.
Product codes and lots: Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.

Product code JJY

K040273Class ILyphochek Assayed Chemistry ControlBio-Rad Laboratories, Inc. / cleared 2004-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)