Siemens Recalls IMMULITE PSA Kits Due to Negative Bias
Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a significant diagnostic inaccuracy (negative bias) in a medical device used for cancer detection, which poses a risk of harm through misdiagnosis or mismanagement, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,379 kits of the IMMULITE/IMMULITE 1000 Systems, Third Generation PSA (prostate-specific antigen) kit. The affected products are distributed in the United States and internationally in Denmark, Brazil, Croatia, and Germany.
The recall was initiated because an investigation confirmed that patient samples exhibit an average negative bias of approximately -22%, with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL. The affected lot numbers are 0336, 0337, and 0338, with expiration dates ranging from January 31, 2017, to May 31, 2017.
This in vitro diagnostic product is used with the IMMULITE and IMMULITE 1000 Analyzers to measure PSA in human serum. The bias may affect the accuracy of quantitative measurements used to aid in the detection and management of prostate cancer.
The recalled product
- Product
- IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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