Avl Omni Modular Analyzer

• 3 recalls, same reason

  • Terminated Z-0335-04 FDA Unclassified (pre-2012) ·initiated 29 Dec 2003 ·via K990092, on the same 510(k)
  • Terminated Z-0337-04 FDA Unclassified (pre-2012) ·initiated 29 Dec 2003 ·via K990092, on the same 510(k)
  • Terminated Z-0336-04 FDA Unclassified (pre-2012) ·initiated 29 Dec 2003 ·via K990092, on the same 510(k)

  The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

• • Terminated Z-0438-03 FDA Unclassified (pre-2012) ·initiated 16 Dec 2002 ·via K990092, on the same 510(k)

  Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K990092 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K944089 Active Cleared 20 Oct 1994

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