Z-3006-2020 Class II Terminated
FDA device recall Z-3006-2020 was initiated by Beckman Coulter Inc. on August 26, 2020 and is designated Class II. Reason for recall: Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results. The recall status is terminated (terminated May 24, 2024). Affected quantity: 21455 assay systems.
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- August 26, 2020
- Termination Date
- May 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21455 assay systems
Product Description
Reason for Recall
Distribution Pattern
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.