Reported Sep 4, 2013 · Terminated
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in…
Siemens Healthcare Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D) |
| 2 | and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits |
| 3 | For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi Systems Analyzers. PMA # P930027/ Device Listing # D002374. Product Usage: For the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and the IMMULITE 2000/ 2000 XPI Systems Analyzers |
- Lot codes and dates
25 of 25 products
Products covered by this recall # Product as published 1 Product Code/Lot # LKPS1 424, Expiration Date 2013-08-31 2 Product Code/Lot # LKPS1 425, Expiration Date 2013-10-31 3 Product Code/Lot # LKPS1 426, Expiration Date 2013-10-31 4 Product Code/Lot # LKPS5 424, Expiration Date 2013-08-31 5 Product Code/Lot # LKPS5 425, Expiration Date 2013-10-31 6 Product Code/Lot # LKPS5 426, Expiration Date 2013-10-31 7 Product Code/Lot # LKPTS1(D) D0104, Expiration Date 2013-08-31 8 Product Code/Lot # L2KPS2 379, Expiration Date 2013-07-31 9 Product Code/Lot # L2KPS2 380, Expiration Date 2013-08-31 10 Product Code/Lot # L2KPS2 381, Expiration Date 2013-10-31 11 Product Code/Lot # L2KPS2 382, Expiration Date 2013-10-31 12 Product Code/Lot # L2KPS2 383, Expiration Date 2013-10-31 13 Product Code/Lot # L2KPS2 384, Expiration Date 2013-10-31 14 Product Code/Lot # L2KPS6 379, Expiration Date 2013-07-31 15 Product Code/Lot # L2KPS6 380, Expiration Date 2013-08-31 16 Product Code/Lot # L2KPS6 381, Expiration Date 2013-10-31 17 Product Code/Lot # L2KPS6 382, Expiration Date 2013-10-31 18 Product Code/Lot # L2KPS6 383, Expiration Date 2013-10-31 19 Product Code/Lot # L2KPS6 384, Expiration Date 2013-10-31 20 Product Code/Lot # L2KPTS2(D) D107, Expiration Date 2013-07-31 - Amount recalled
- 24,361 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Siemens Healthcare Diagnostics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.