Announcements

BLUE LINE MEMO:

Recall of Siemens Clinitest Urine Pregnancy Test Kits

After receiving a number of customer complaints (including one from us at Duke) concerning apparent false Borderline Positive and false Positive results and confirming this through their own internal testing, Siemens has initiated an immediate national recall of all lots of its Clinitest hCG Test Kits.  These kits contain test cartridges that are used by the Duke Emergency Department and several Duke clinics to perform the HCG Pregnancy Test-Qualitative Urine on the Siemens Status point-of-care analyzer.  Therefore, effective immediately, Urine Pregnancy testing on this device must be discontinued until further notice.

The DUH Point-of-Care Testing Laboratory has obtained access to a previously validated lot of  Quidel Quick-Vue hCG Combo Test kits.  This was the method in use here prior to adoption of the Siemens Status Urine Pregnancy Test.  The procedure manual and on-line training module for this test will be reloaded onto the Employee Intranet by Monday, December 19.  Product is available to authorized testing locations by ordering in SAP.  Upon arrival, sites must contact the Point-of-Care Testing Laboratory to schedule (re)training of operators.  The capability to perform rapid urine pregnancy tests will be restored to all locations as soon as possible (hopefully by the end of next week).

In the interim the HCG Pregnancy Test-Quantitative Serum/Plasma is available through the Rapid Response Laboratory 24/7/365 and also at the Franklin Core Laboratory.

We regret any inconvenience caused by this abrupt recall but have taken this action to protect the safety of our patients.

Please refer all inquiries to Susan Utley, Supervisor of the DUH Point-of-Care Testing Laboratory at 919-681-6706 (utley003@mc.duke.edu) or Dr. Bruce Lobaugh, Director of Clinical Pathology Laboratories at 919-681-6335 (bruce.lobaugh@duke.edu).

Thanks for your continued support of DUHS Clinical Laboratories.

Bruce Lobaugh, Ph.D., HCLD(ABB), Director, DUHS Clinical Pathology Laboratories