Recall Z-1003-2024 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Siemens Healthcare Diagnostics, Inc.
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
| Date | Feb 7, 2024 (initiated Dec 15, 2023) |
| Status | Open, Classified |
| Reason | Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 12/19/23 was sent to customers. Actions to be Taken by the Customer: Siemens Healthineers recommends batch testing samples for Atellica CH IgM_2 as follows: 1. Remove and discard any Atellica CH IgM_2 reagent packs onboard the analyzer. 2. Load a single fresh Atellica CH IgM_2 reagent pack onto the analyzer. 3. Perform a Lot calibration and process Quality Control (QC). 4. Immediately process a batch of patient samples and conclude with a repeat run of QC. Patient results should not be reported until the QC performed at the end of t |
| Quantity | 7,075 units (927 US, 6148 OUS) |
| Distribution | 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, |
| FDA record | Open on fda.gov |