Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

FDA device recall Z-1003-2024 · posted 2024-02-07 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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 the batch run has been assessed. - If the QC results are within the established range, patient results can be reported. - If the QC results are not within the established range, do not report patient results and repeat steps 1 4 above. 5. Remove and discard the Atellica CH IgM_2 reagent pack at the end of the batch run. Siemens Healthineers does not recommend using the ADVIA IgM_2 reagent on the Atellica CH or Atellica CI Analyzers. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CFN

Quantity affected

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

Date initiated

2023-12-15

Date posted

2024-02-07

Location

Tarrytown, NY

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