FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2080-2017
- Recalling firm
- Beckman Coulter Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-04-03
- Posted
- not on file
- Terminated
- 2018-05-31
- 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. 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
- 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, 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.
- Lot, serial or model codes
- all lots
- 510(k) numbers
- ["K093458"]
- PMA numbers
- not on file
- Product code
- JFY
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28