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Z-2175-2008

AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella...

Abbott Medical / initiated 2008-06-02 / Terminated / root cause: design
FDA source (opens on fda.gov)

Abbott Laboratories began a recall of AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2175-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
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.
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Reason for recall
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.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
33,485 reagent kits
Distribution
Worldwide Distribution including USA, territory of Puerto Rico, and countries of Australia, Bahamas, Canada, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Mexico, Peru, New Zealand, Panama, Singapore, South Korea, Thailand, Turks & Caicos and Uruguay.
Product codes and lots
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)