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Terminated

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

FDA Recall Z-1233-2010 · Posted 2010-04-06

Recalling FirmVital Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJY
Date Initiated2009-12-04
Date Terminated2012-07-25
Product Quantity871 Kits

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040273LYPHOCHEK ASSAYED CHEMISTRY CONTROLBio-Rad Laboratories, Inc. · 2004-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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