VARIANT nbs 250-3003
VARIANT nbs 250-3003 (2503003) 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 00847817008306), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00847817008306 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051072 | Date12 May 2005 | StatusActive |
Official records
- AccessGUDID record 00847817008306
- FDA 510(k) database K051072
Across registries
- FDA 510(k) K051072 decided 12 May 2005 Active
- FDA GUDID UDI-DI 00847817008306 listed 12 Sep 2016 Listed
Recalls
-
- Ongoing Z-1208-2022
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
- Cleared FDA 510(k) K051072
- Listed FDA GUDID 00847817008306
- Recall initiated FDA recalls Z-1208-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VARIANT nbs
- Generic name
- Inherited haemoglobinopathy IVD, reagent
- Model / Ref / Catalog
- 250-3003, 2503003
- Primary DI / UDI-DI
- 00847817008306
- 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
Similar devices
Other devices filed under FDA product code GKA (ABNORMAL HEMOGLOBIN QUANTITATION).
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- CAPI 3 HEMOGLOBIN(E) by SEBIA
- PARAGON ACID HEMOGLOBIN REAGENT KIT by Beckman Instruments, Inc.
- VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH by Bio-Rad Laboratories, Inc., Clinical Systems Divis
- Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software by Bio-Rad Laboratories, Inc.
- RESOLVE-HB by Isolab, Inc.
- SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 by SEBIA
- Primus Variant System PVS99 by Primus Corp.
- Variant Hemoglobinopathy Program by Bio-Rad
- Variant NBS Sickle Cell Program by Bio-Rad Laboratories, Inc.