Beckman Coulter Inc.: Medical Device Recall in 2017 - (Recall #: Z-2080-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 3, 2017

Date Posted: May 24, 2017

Recall Number: Z-2080-2017

Event ID: 76962

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.

Status: Terminated

Product Quantity: 12,665 units total (1,399 units in US)

Code Information:

all lots

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated