Atellica IM Folate test kit recalled for measurement bias issues
Siemens Healthcare is recalling 1,865 Atellica IM Folate 700 diagnostic kits nationwide and internationally. The kits may produce inaccurate folate test results when whole blood calibration is used instead of serum calibration.
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 device with no reported illnesses or injuries. The hazard—negative bias in test results—is a technical risk that could affect diagnostic accuracy, but actual patient harm has not been documented. Per the rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
Siemens Healthcare Diagnostics is recalling 1,865 Atellica IM Folate 700 diagnostic test kits. These kits are used to measure folate levels in patient blood samples. The recall affects lot numbers 16097337, 44861343, 63869345, and all higher lot numbers until the Instructions for Use are updated.
The kits may produce inaccurate test results due to negative bias when whole blood calibration is used instead of the correct serum calibration. This measurement error could lead to incorrect patient test results that do not accurately reflect folate levels.
The affected kits have been distributed nationwide across the United States and internationally. Healthcare facilities and laboratories currently using these kits should review their testing procedures and contact Siemens Healthcare Diagnostics for guidance on the appropriate calibration methods. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-bias
- diagnostic-inaccuracy
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 (1)
- 44861343
Distribution
Distributed nationwide across the United States.
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