Flawed PSA test kits manufactured by German healthcare giant

Last month, a field safety notice was distributed by Siemens Healthcare Diagnostics warning of a bias in their PSA test levels of approximately 20-23 percent.

So why would a false elevation of Prostate Specific Antigens concern a patient?

“We know that this level can be elevated in prostate cancer so it's one of the ways we can screen for prostate cancer,” said Dr. Thomas Clements with Urology of Central Pa. “It's a quantitative test that is measuring the amount of this protein-per-volume of blood that's given.”

The medical director of Central Pennsylvania Alliance Laboratory in York said that Siemens recently informed them about the recall of a specific lot of testing kits.

According to the FDA's website, the Immulite 1000 kits are “lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older.”

Many in the Midstate fear that the faulty results may have prompted some men to undergo unnecessary procedures like a biopsy.

Clements said that's unlikely. he said that while PSA tests can save lives, rarely would elevated levels be the sole reason behind further treatment.

The flawed testing kits have been recalled from May of 2012 to July of this year.

Central Pennsylvania Alliance Laboratory is awaiting an answer from Siemens as to why it took one whole year for them to discover the problem.

One in six men will be diagnosed with prostate cancer in their lifetime. Experts agree that it can be easily treated with early detection.

PinnacleHeath has offered to retest their patients for free.

 

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