FDA Medical Device Recalls (openFDA)
Vital Diagnostics, Inc.: Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
- Recall number
- Z-1233-2010
- Recalling firm
- Vital Diagnostics, Inc.
- Product
- Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
- Status
- Terminated
- Initiated
- 2009-12-04
- Posted
- 2010-04-06
- Terminated
- 2012-07-25
- 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.
- Lot, serial or model codes
- Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.
- 510(k) numbers
- ["K040273"]
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1717966
- Firm city
- Lincoln
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28