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Autoimmune EIA 230AW

by Bio-Rad Laboratories

Autoimmune EIA 230AW is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K954723 on 15 Dec 1995 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817007026), active as of 23 Oct 2026. 6 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

510(k) K954723

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847817007026 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK954723 Date15 Dec 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K954723 decided 15 Dec 1995 Active
  • FDA GUDID UDI-DI 00847817007026 listed 12 Sep 2016 Listed

Recalls

6 recalls · FDA

    • 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 .

Timeline

8 dated events

  1. Cleared FDA 510(k) K954723
  2. Recall initiated FDA recalls Z-0613-2011
  3. Recall initiated FDA recalls Z-0540-2011
  4. Recall initiated FDA recalls Z-1478-2011
  5. Recall initiated FDA recalls Z-0539-2011
  6. Recall initiated FDA recalls Z-1479-2011
  7. Recall initiated FDA recalls Z-0612-2011
  8. Listed FDA GUDID 00847817007026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Autoimmune EIA
Generic name
Multiple antinuclear antibody (ANA) IVD, reagent
Model / Ref / Catalog
230AW
Primary DI / UDI-DI
00847817007026
510(k) Number
FDA product code
LKJ
GMDN term
Multiple antinuclear antibody (ANA) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 60 Milliliter

Related devices

Category: Multiple antinuclear antibody (ANA) screening IVD, reagent

Cleared under the same submission (K954723)

and 8 more cleared under K954723

Similar devices

Other devices filed under FDA product code LKJ (ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)