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Abbott Axsym Folate

by Abbott Laboratories 510(k)

Active United States

510(k) K972232

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972232 Date24 Jun 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

6 recalls · FDA

    • Terminated Z-1049-2009 FDA Unclassified (pre-2012) initiated 19 Jan 2009

    Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

    • Terminated Z-1029-2007 FDA Unclassified (pre-2012) initiated 23 Apr 2007

    Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

  • 4 recalls, same reason

    • Terminated Z-0367-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K972232, on the same 510(k)
    • Terminated Z-0365-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K972232, on the same 510(k)
    • Terminated Z-0366-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K972232, on the same 510(k)
    • Terminated Z-0368-04 FDA Unclassified (pre-2012) initiated 16 Dec 2003 via K972232, on the same 510(k)

    The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.

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

Specification

510(k)

510(k) Number
FDA Product Code
CGN
Device Class
Class II
Regulation
21 CFR Part 862.1295
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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