Z-1984-2011

VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and...

Name: Z-1984-2011 VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and...
Creator: Bio-Rad Laboratories Inc
Published: 2010-04-14
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-04-14 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories Inc began a recall of VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The... on 2010-04-14. The reason FDA records is "The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1984-2011
Status: Terminated
Initiated: 2010-04-14
Posted: 2011-04-14
Terminated: 2011-08-08
Recalling firm: Bio-Rad Laboratories Inc.
Product: VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.
Product code: GKA Abnormal Hemoglobin Quantitation
Reason for recall: The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Bio-Rad Laboratories sent out the Urgent Medical Device Correction notice on 4/14/2011, by Federal Express. An Update was sent on May 13th, advising customers of a minor discrepancy in the parameters included on the affected Resin Update CD-ROMs. Customers were instructed to examine your inventory for the affected reorder pack lots. Please complete and return the Medical Device Correction Response Form Questions regarding this recall please call (510) 724-6114.
Quantity in commerce: 658 units
Distribution: Worldwide Distribution -- USA , Brazil, Canada, Caribbean, France, Italy, and United Kingdom.
Product codes and lots: Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210. Resin Update CD-ROM, 250-3020 lot # CA 00092 Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000;

Product code GKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)