AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is
FDA device recall Z-2175-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LFX
- Quantity affected
- 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, Gu
- Date initiated
- 2008-06-02
- Date posted
- 2008-09-16
- Date terminated
- 2008-11-05
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM RUBELLA IGG ANTIBODY ASSAY (K954045) | Abbott Laboratories | 1996-09-24 |