Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Reported: May 24, 2017 Initiated: April 3, 2017 #Z-2081-2017
Product Description
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Reason for Recall
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 128,718 units total (47,858 units in US)
- Distribution
- Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.. Recalled by Beckman Coulter Inc.. Units affected: 128,718 units total (47,858 units in US).
Why was this product recalled? ▼
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2081-2017.
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