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U.S. Department of Health and Human Services

Class 3 Device Recall AxSYM Rubella IgG Reagent Pack

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 Class 3 Device Recall AxSYM Rubella IgG Reagent Packsee related information
Date Initiated by FirmJune 02, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on November 05, 2008
Recall NumberZ-2175-2008
Recall Event ID 48626
510(K)NumberK954045 
Product Classification Enzyme - Product Code LFX
ProductAxSYM 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.
Code Information 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)
FEI Number 1415939
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information ContactAbbott Customer Support
877-422-2688
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionConsignees 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 Commerce33,485 reagent kits
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LFX
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