FDA recall Z-3006-2020

Product

BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

Reason for recall

Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Czech Republic, Germany, Hungary, India, Ireland, Italy, Jordan, Lebanon, Malaysia, Mexico, Nepal, Pakistan, Panama, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Key facts

Status

Terminated

Initiation date

2020-08-26

Report date

2020-09-30

Termination date

2024-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3006-2020