Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results
Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.
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: The recall involves a diagnostic device with a confirmed significant negative bias (-22%) that could lead to inaccurate prostate cancer screening results, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling two lots of the IMMULITE/IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kits. The recall involves Lot D01196 (expiration date 2016-12-31) and Lot D0120 (expiration date 2017-03-31). A total of 1,379 kits are affected, with 190 kits distributed in the United States and 1,189 kits distributed internationally in Denmark, Brazil, Croatia, and Germany.
The recall was initiated because Siemens confirmed that patient samples tested with these kits exhibit an average negative bias of approximately -22%, with a range of -16% to -27%. This bias affects samples recovering from 0.08 to 16.2 ng/mL. The kits are used for in vitro diagnostic purposes to measure PSA in human serum as an aid in the detection and management of prostate cancer.
Healthcare facilities and laboratories that have used or possess these specific lots should stop using the kits and contact Siemens Healthcare Diagnostics for further instructions. Patients who have had PSA tests performed using these specific lots should consult their healthcare provider to discuss the potential impact on their results.
The recalled product
- Product
- IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US 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 huma
- 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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