Abbott Laboratories AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
list 3B23-20: lots 61151M101 (exp. 12/28/08), 61151M100 (exp. 12/28/08), 60943M101 (exp. 09/22/08), 60943M100 (exp. 09/22/08), 58296M101 (exp. 10/05/08), 58296M100 (exp. 10/05/08), 58295M101 (exp. 09/22/08), 58295M100 (exp. 09/22/08), 58294M101 (exp. 09/01/08), 58294M100 (exp. 09/01/08), 57577M201 (exp. 08/10/08), 57577M200 (exp. 08/10/08), 56659M201 (exp. 07/21/08), 56659M200 (exp. 07/21/08), 56323M101 (exp. 06/30/08), 56323M100 (exp. 06/30/08), 55922M100 (exp. 06/20/08), 55922M101 (exp. 06/20/08), 55921M101 (exp. 06/09/08), and 55921M100 (exp. 06/09/08)
Products Sold
list 3B23-20: lots 61151M101 (exp. 12/28/08), 61151M100 (exp. 12/28/08), 60943M101 (exp. 09/22/08), 60943M100 (exp. 09/22/08), 58296M101 (exp. 10/05/08), 58296M100 (exp. 10/05/08), 58295M101 (exp. 09/22/08), 58295M100 (exp. 09/22/08), 58294M101 (exp. 09/01/08), 58294M100 (exp. 09/01/08), 57577M201 (exp. 08/10/08), 57577M200 (exp. 08/10/08), 56659M201 (exp. 07/21/08), 56659M200 (exp. 07/21/08), 56323M101 (exp. 06/30/08), 56323M100 (exp. 06/30/08), 55922M100 (exp. 06/20/08), 55922M101 (exp. 06/20/08), 55921M101 (exp. 06/09/08), and 55921M100 (exp. 06/09/08)
Abbott Laboratories is recalling AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSY due to An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Ca. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.
Recommended Action
Per FDA guidance
Consignees were sent a Product Correction-Immediate Action Required letter on 6/2/08. The letter informed users of calibration failures due to elevates Calibrator A or Master Calibrator 1 rates when attempting to calibrate the AxSYM Rubella IgG assay and that they must clarify the Rubella IgG Calibrator A or the Rubella IgG Master Calibrator 1 and the Rubella IgG Negative Control by centrifugation at >/= 10,000 x g for 10 minutes prior to testing. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026