—#71762

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.

FDA product code: LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K954045
Affected lot / code info: 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)

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-06-02
Posted by FDA: 2008-09-16
Terminated: 2008-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71762. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.