Enzyme Immunoassay Ana Screening Test Kit

• • Terminated Z-0612-2011 FDA Unclassified (pre-2012) ·initiated 24 Jun 2010

  Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..

• 2 recalls, same reason

  • Terminated Z-0540-2011 FDA Unclassified (pre-2012) ·initiated 1 Mar 2010
  • Terminated Z-0539-2011 FDA Unclassified (pre-2012) ·initiated 1 Mar 2010

  The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.

• • Terminated Z-1478-2011 FDA Unclassified (pre-2012) ·initiated 1 Mar 2010

  Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.

• • Terminated Z-1479-2011 FDA Unclassified (pre-2012) ·initiated 1 Mar 2010

  The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.

• • Terminated Z-0613-2011 FDA Unclassified (pre-2012) ·initiated 24 Feb 2010

  False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .

510(k) Number

K954723 ↗

FDA Product Code

LKJ

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Enzyme Immunoassay Anti-SS-A/Ro Antibody Test Kit

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