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Total immunoglobulin M (IgM total) IVD, kit… recallZ-1003-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Dec 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1003-2024
Status
Open, Classified
Initiated by the company
Dec 15, 2023
Posted by the FDA
Feb 7, 2024
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
7,075 units (927 US, 6148 OUS)
Product code
CFN
FDA submissions
K151767, K992662
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, 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.

Product description

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

Code information (models, lots, serial numbers)

Siemens Material Number (SMN): 11097620; UDI DI: 00630414595627; Lot No. (Exp. Date): 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), 232025 (11/01/2024).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

7 devices cleared under K151767, K992662 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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