Z-0908-2010

Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1...

Name: Z-0908-2010 Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1...
Creator: Bio-Rad Laboratories
Published: 2008-08-20
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2008-08-20 / Terminated / root cause: manufacturing process

FDA source

Bio-Rad Laboratories began a recall of Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop... on 2008-08-20. The reason FDA records is "Elevated optical density (OD) values with the kit Negative Control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0908-2010
Status: Terminated
Initiated: 2008-08-20
Posted: 2010-03-02
Terminated: 2010-04-08
Recalling firm: Bio-Rad Laboratories Inc.
Product: Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
Product code: LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Reason for recall: Elevated optical density (OD) values with the kit Negative Control.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.
Quantity in commerce: 82 kits
Distribution: Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
Product codes and lots: Lot F1108

Product code LFX

K961053Class IISeraquest Rubella IggQuest Intl., Inc. / cleared 1996-09-04

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)