Z-0440-2022 Class II Terminated
FDA device recall Z-0440-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on December 1, 2021 and is designated Class II. Reason for recall: ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a … The recall status is terminated (terminated July 7, 2023). Affected quantity: US: 46 units OUS: 794 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- December 1, 2021
- Termination Date
- July 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 46 units OUS: 794 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.