Vital Diagnostics, Inc. ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Brand
Vital Diagnostics, Inc.
Lot Codes / Batch Numbers
Level 1, Lot Number 9137010 and Level 2, Lot Number 9138010.
Products Sold
Level 1, Lot Number 9137010 and Level 2, Lot Number 9138010.
Vital Diagnostics, Inc. is recalling ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry met due to Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer me. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026