PSA Tests – Problems – Just because you get a result does not mean that it is accurate.

 

Urgent Field Safety Notice

4006

June 2013

PSA Assays for the Following Systems:

 

IMMULITE®

IMMULITE® 1000

IMMULITE® 2000

IMMULITE® 2000 XPi

 

PSA Positive Bias to WHO 96/670

Reason for Recall

Siemens Healthcare Diagnostics has confirmed an overall average positive bias of approximately 20% –23% across the assay range relative to WHO 96/670 with the IMMULITE Systems PSA assays.   This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO).  Other commercially available controls may show this bias.  Refer to Table 2 for approximate percent bias for specific concentrations. 

Our records indicate that you have or may have received the following product:

Table 1.      IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Affected Lots

Assay Test Code Catalog Number Siemens Material Number (SMN) Lot Number
IMMULITE/IMMULITE 1000  PSA PSA LKPS1 10380960 422, 423, 424, 425,  426
IMMULITE/IMMULITE 1000 PSA PSA LKPS5 10380949
IMMULITE/IMMULITE 1000  PSA PTS LKPTS1(D) 10706279 D103,  D104
IMMULITE 2000/IMMULITE 2000 XPi  PSA PSA L2KPS2 10380986 377, 378, 379, 380, 381, 382, 383, 384
IMMULITE 2000/IMMULITE 2000 XPi  PSA PSA L2KPS6 10380996
IMMULITE 2000/IMMULITE 2000 XPi  PSA PTS L2KPTS2(D) 10706281 D104, D106, D107, D108, D109
IMMULITE 2000/IMMULITE 2000 XPi  PSA PTS L2KPTS6(D) 10706282


Table 2.      Approximate Percent Bias for Specific Concentrations

Expected Dose (ng/mL)

Mean Recovery

Mean % Bias

Lower 95th CI

Lower 95% Bias

Upper 95th CI

Upper 95% Bias

1.0

1.3

26%

1.2

19%

1.3

33%

2.0

2.5

23%

2.3

15%

2.6

30%

5.0

6.1

23%

5.7

13%

6.6

32%

10.0

13.0

30%

12.5

25%

13.6

36%

25.0

31.8

27%

30.2

21%

33.3

33%

50.0

57.0

14%

53.8

8%

60.3

20%

75.0

83.3

11%

78.2

4%

88.4

18%

150

152

1%

138

-8%

165

10%

The positive bias was determined to begin with kit lots released in February 2012:

§  IMMULITE/IMMULITE 1000 kit LKPS lot 422 and LKPTS lot D103.

§  IMMULITE 2000/IMMULITE 2000 XPi kit lots L2KPS 377 and L2KPTS lot D104.

The root cause of this bias is under investigation.

Risk to Health

A positive bias in PSA results may impact clinical interpretation of test results.  In cases where the true values are near the cut off, the bias may increase the likelihood of a decision to initiate additional diagnostic tests (including prostatic biopsy).  The risk of unnecessary biopsy is mitigated by the fact that the clinician/patient decision for prostatic biopsy is based on a number of factors in addition to a PSA result, including patient age, digital rectal exam findings, clinical signs or symptoms or co morbidities such as prostatic inflammation or infection.

Look Back

The decision to perform a biopsy is usually undertaken within a short period of time from the assay result. Therefore a conservative look back period can be limited to two months of test results.  For results that were recorded as abnormal in your facility please notify your physicians of this communication. Actions by the clinician may be to reconsider a scheduled biopsy based on the test result taking into account the other factors that made biopsy a consideration.

Clinical decisions are the responsibility of the patient’s caregiver. The positive bias does not negate the necessity of a biopsy if other findings support the decision.


Actions to be Taken by the Customer

Discontinue use of and discard the kits remaining in inventory.  There are no replacement PSA kits available at this time. The projected date of availability is the week of July 8, 2013.

Please contact your local Siemens representative for assistance with determining appropriate PSA testing solutions for your laboratory. 

In addition, please perform the following:

·         Complete and return the Field Correction Effectiveness Check form attached to this letter within seven (7) days.

·         Keep this letter with your laboratory records.

·               Forward this letter to whomever you may have distributed these products.

If you have any questions or need additional information, please contact your Siemens Customer Care Center or your local technical support representative.

IMMULITE is a trademark of Siemens Healthcare Diagnostics.


FIELD CORRECTION EFFECTIVENESS CHECK

PSA Positive Bias to WHO 96/670

 

This response form is to confirm receipt of the enclosed Siemens Healthcare Diagnostics Urgent Field Safety Notice # 4006 dated June 2013 regarding IMMULITE Systems PSA Positive Bias to WHO 96/670. Please read each question and indicate the appropriate answer.  Fax this completed form to Siemens Healthcare Diagnostics at the fax number indicated at the bottom of this page.

1.    I have read and understood the Urgent Field Safety Notice instructions provided in this letter. Yes  ð No  ð
2.    Do you now have any of the noted product on hand?  (Please check inventories before answering.) Yes  ð No  ð
3.    If the answer to the question above is yes, how much product do you have on hand and quantity to be discarded?  
Name of person completing questionnaire:

 

 

Please note:  Replacements will be provided as inventory becomes available.  The projected date of availability is the week of July 8, 2013.

 

Product Description

Product Catalog# /  Lot #

Quantity Discarded Replacement Kits Required
     
     
     

 

Title:      
Institution:   Instrument Serial Number:  
Street:      

 

City:   State: Phone:

 

Customer Sold To #:   Customer Ship To #:  

PLEASE FAX THIS COMPLETED FORM TO THE TECHNICAL SOLUTIONS CENTER AT (###) ###-####.