Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Reported: July 5, 2017 Initiated: May 9, 2017 #Z-2638-2017
Product Description
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Reason for Recall
The Access immunoassays are susceptible to biotin interference.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 249,597 units total (9,388 units in US)
- Distribution
- Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Malawi, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, Zambia, Zimbabwe
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687. Recalled by Beckman Coulter Inc.. Units affected: 249,597 units total (9,388 units in US).
Why was this product recalled? ▼
The Access immunoassays are susceptible to biotin interference.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2017. Severity: Moderate. Recall number: Z-2638-2017.
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