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Friday, 20th April

Like any great Life Sciences company, Beckman Coulter’s scandals run deep.

In August 2011, Beckman Coulter’s General Manager in Turkey was exposed for breaking several trade laws in addition to general corruption. In our opinion, the consequence is never steep enough however Beckman Coulter was banned from doing business for an entire year in Turkey. It is not surprising that a company willing to enter contracts and supply to Huntingdon Life Sciences would be caught breaking the law. Apparently corruption runs in the “family” considering Huntingdon has been exposed at least seven times in separate undercover investigations for violating animal protection laws, falsifying data in order to please paying customers, and in one experiment alone, HLS breached over 520 Good Laboratory Practice Guidelines.

Recalls of pharmaceuticals are commonplace to most of the public. We often hear about a drug that has extreme or adverse side affects that customers are not forewarned about. But what about the equipment utilized by health care professionals or used in the biomedical field?

In April 2011, Beckman Coulter was ordered a Class 1 recall by the U.S. Food and Drug Administration (FDA) for several of their medical devices. The FDA classified the recall as the “most serious type of recall [Class 1]” which “involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death”. Beckman Coulter distributed these medical devices from March 1997 to April 2011, allowing fourteen years for a grave and serious disaster to happen at any moment (and we will never really know if something did happen as a result of their machines’ faultiness!).

Of course April 2011 was not the first of Beckman Coulter’s recalls nor is it their last. In February 2010, Beckman Coulter recalled their troponin assay kits that assisted physicians in diagnosing heart attacks. The test kits must be accurate otherwise physicians would believe a patient is having a heart attack when they are not. Beckman’s troponin assay kits provided alarming amounts of false positives leading doctors in the wrong direction and putting human lives on the line.

Months after the April 2011 recall, Beckman was hit with a class-action lawsuit concerning the modification of the troponin assay kits. The plaintiffs, former Beckman shareholders, filed the suit against Beckman for violating Securities and Exchange Commission (SEC) rules due to the fact that Beckman failed to disclose that such kits were modified without “proper FDA approval” and the necessary clearance to put such instruments back on the market.

As if those messy recalls were not enough on their own to shame the company, Beckman Coulter has received not just one but three warning letters (see letters at links below) from the FDA for violating “good manufacturing practices”, not seeking the appropriate “approval design changes” before equipment was discharged and the failure to take “corrective and preventative action” in order to address the violations. And just last month, Beckman Coulter faced another Class 2 recall of almost 2,000 medical device units.

It’s seems safe to assume that no one at Beckman Coulter has taken any interest in running an ethical business while keeping the consumer in mind. One must begin to wonder if the Beckman Coulter powers that be are more concerned with vending quality medical instruments or with stuffing their pockets with as much corporate cash as they can. It’s very clear that when it comes to doing their research, Beckman Coulter leaves more than a little something to be desired.

Whether it’s quality control or supplying responsibly, Beckman Coulter gets it wrong every time.

|| Banned from Turkey August 20, 2011 || FDA Recall February 2010 || FDA Class 1 Recall April 5, 2011 ||
|| FDA Class 2 Recall March 20, 2012 || Troponin Lawsuit || Warning Letter June 21, 2010 ||
|| Warning Letter August 9, 2011 || Warning Letter November 1, 2011 ||


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