Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.
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 medical device used for cancer detection that is failing to meet performance expectations, creating a risk of harm through inaccurate results, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay. The recall involves 6,697 kits distributed worldwide, including 1,646 kits in the United States and 5,081 kits in other countries. The affected lots are L2KPS2/L2KPS6 (Lots 408, 409, 410) and L2KPTS2/L2KPTS6 (Lots D112, D123, D124).
The recall was initiated because the assays are not meeting the current High-dose Hook Effect expectation described in the Instructions for Use. This performance issue may affect the accuracy of quantitative PSA measurements in human serum, which are used as an aid in the detection and management of prostate cancer.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (5)
- All lots L2KPS2/L2KPS6 - Lots 408
- 409
- 410 L2KPTS2/L2KPTS6 - Lots D112
- D123
- D124
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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