Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias
Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential negative bias in diagnostic test results, which qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 7,075 units (927 US, 6,148 international) of its Total Immunoglobulin M (IgM) in vitro diagnostic kit. The reagent is used with the Atellica CH analyzer to measure immunoglobulin M levels in patient samples via nephelometry/turbidimetry.
The recall addresses a potential for negative bias in quality control and patient sample results when using the Atellica CH Immunoglobulin M_2 reagent. This bias could affect the accuracy of test results.
Affected lot numbers are 221764 (10/01/2023), 221829 (02/01/2024), 231915 (06/01/2024), and 232025 (11/01/2024). U.S. distribution was nationwide across most states and Puerto Rico; international distribution covered multiple countries including Argentina, Australia, Austria, Canada, Germany, France, Japan, Mexico, and United Kingdom.
Healthcare providers and laboratories using affected lots should discontinue use and contact Siemens Healthcare Diagnostics for product replacement instructions and guidance on quality control verification.
The recalled product
- Product
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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).
Distribution
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