Z-1003-2024 Class II Ongoing
FDA device recall Z-1003-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on December 15, 2023 and is designated Class II. Reason for recall: Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. The recall status is ongoing. Affected quantity: 7,075 units (927 US, 6148 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,075 units (927 US, 6148 OUS)
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and PR; The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Curacao, Czech Republic, Denmark, Egypt, Estonia, Finland France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kenya, Kuwait, Latvia, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom, Uruguay, Vatican City, Vietnam, Zaire.