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VARIANT nbs 250-3001

by Bio-Rad Laboratories

VARIANT nbs 250-3001 (2503001) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K051072 on 12 May 2005 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817008283), active as of 23 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

510(k) K051072

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 Number00847817008283 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK051072 Date12 May 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051072 decided 12 May 2005 Active
  • FDA GUDID UDI-DI 00847817008283 listed 12 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1208-2022 FDA Class II initiated 7 Apr 2022

    The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CDROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.

Timeline

3 dated events

  1. Cleared FDA 510(k) K051072
  2. Listed FDA GUDID 00847817008283
  3. Recall initiated FDA recalls Z-1208-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VARIANT nbs
Generic name
Inherited haemoglobinopathy IVD, reagent
Model / Ref / Catalog
250-3001, 2503001
Primary DI / UDI-DI
00847817008283
510(k) Number
FDA product code
GKA
GMDN term
Inherited haemoglobinopathy IVD, reagent
Device class
Class II
Regulation number
864.7415
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inherited haemoglobinopathy IVD, reagent

Cleared under the same submission (K051072)

and 2 more cleared under K051072

Similar devices

Other devices filed under FDA product code GKA (ABNORMAL HEMOGLOBIN QUANTITATION).

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)