Variant NBS Sickle Cell Program
by Bio-Rad Laboratories, Inc. 510(k)
Active Open recall
510(k) K051072
Regulatory status
Recall ongoing. 1 ongoing FDA recall names this device. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051072 | Date12 May 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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.
Specification
- Full name
- Bio-Rad Variant Nbs Sickle Cell Program
- 510(k) Number
- FDA Product Code
- GKA
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7415
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Bio-Rad Variant NBS Sickle Cell Program is an abnormal hemoglobin quantitation device designed for the qualitative screening of hemoglobins. It provides a rapid 3-minute screen for the presence of hemoglobins F, A, S, D, C, and E in eluates of neonatal blood samples.
This program utilizes one-step sample preparation for neonatal blood collection. The device is regulated under FDA 510(k) clearance K051072 and is classified under regulation number 864.7415.
From the manufacturer
The Bio-Rad VARIANTnbs Sickle Cell Program offers a rapid 3-minute qualitative screen for the presence of hemoglobins F, A, S, D, C, and E in eluates of neonatal blood collected with one step sample preparation.
Welcome to the Bio-Rad Library of Variants - a compendium of HPLC cases. This Digital Library contains case reports of variants hemoglobin provided by a select group of reference centers belonging to the worldwide community of laboratories actively working on detection of sickle cell, thalassemia and other hemoglobinopathies.
Other devices from Bio-Rad Laboratories, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the primary purpose of the Bio-Rad Variant NBS Sickle Cell Program?
The Bio-Rad Variant NBS Sickle Cell Program is an abnormal hemoglobin quantitation device used for the qualitative screening of hemoglobins F, A, S, D, C, and E in neonatal blood samples.
How long does it take to perform a screening with this device?
This device is designed for rapid screening, providing results in approximately 3 minutes per sample using eluates from neonatal blood collections.
How is the sample prepared for analysis?
The program utilizes a one-step sample preparation process specifically designed for neonatal blood collection to streamline the screening workflow.
What is the regulatory status of this device?
The Bio-Rad Variant NBS Sickle Cell Program is regulated under FDA 510(k) clearance K051072 and is classified under regulation number 864.7415 for abnormal hemoglobin quantitation.