Z-2241-2021 Class II Terminated
FDA device recall Z-2241-2021 was initiated by Beckman Coulter, Inc. on June 23, 2021 and is designated Class II. Reason for recall: Software anomalies that may lead to the generation of erroneous results. The recall status is terminated (terminated July 2, 2026). Affected quantity: 1,085 (482 US & 603 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 23, 2021
- Termination Date
- July 2, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,085 (482 US & 603 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and Hawaii. The countries of Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Israel, Italy, Kenya, Korea, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, U.A.E, Ukraine, United Kingdom, and Vietnam.