| Class 2 Device Recall Synchron Systems Salicylate Reagent | |
Date Initiated by Firm | April 03, 2017 |
Create Date | May 12, 2017 |
Recall Status1 |
Terminated 3 on May 31, 2018 |
Recall Number | Z-2084-2017 |
Recall Event ID |
76962 |
510(K)Number | K014173 |
Product Classification |
Colorimetry, salicylate - Product Code DKJ
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Product | Salicylate Reagent (SALY 2 x 45), Catalog No. 378194.
Intended for quantitative determination of salicylate concentration in human serum or plasma. |
Code Information |
all lots |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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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 | 50,645 units total (43,816 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 |
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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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510(K) Database | 510(K)s with Product Code = DKJ
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