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U.S. Department of Health and Human Services

Class 2 Device Recall Synchron Systems Cholesterol Reagent

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  Class 2 Device Recall Synchron Systems Cholesterol Reagent see related information
Date Initiated by Firm April 03, 2017
Create Date May 12, 2017
Recall Status1 Terminated 3 on May 31, 2018
Recall Number Z-2081-2017
Recall Event ID 76962
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
Product Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825

Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Code Information all lots
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall letter dated 4/3/17 was sent to customers to inform them that Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole, Sulfasalazine, and Sulfapyridine. Customers are informed that with the administration of these drugs, the effects to patient analytes are: - Metamizole (Dipyrone)  may generate false low Cholesterol, Enzymatic Creatinine, HDL Cholesterol, Lactate, Triglycerides and Uric Acid results. -Sulfasalazine  may generate false high Salicylate results. -Sulfapyridine  may generate false low Salicylate results. Customers are informed of the action and resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center -Via http://www.beckmancoulter.com/customersupport/support -Via phone, call 1-800-854-3633 in the United States and Canada Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 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.
Total Product Life Cycle TPLC 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.
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