Recall Z-2080-2017 ยท JFY Enzymatic Method, Creatinine
Beckman Coulter Inc.
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
| Date | Apr 3, 2017 |
| Status | Terminated |
| Reason | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results. |
| Root cause | 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. C |
| Quantity | 12,665 units total (1,399 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, Neth |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 Beckman Coulter, Inc., Dec 4, 2009 |