Lab Error Triggers Product Recall

There’s a third-party contract lab located somewhere in Canada that needs to review its Good Laboratory Practices and lab sanitation protocols.

On October 5, 2011, the Canadian Food Inspection Agency (CFIA), in conjunction with Foodfest International 2000 Inc., warned the Ontario public that Strubs ready-to-eat Danish Style Smoked Grav-Lox Atlantic Salmon (Lot code 09262011) should not be consumed.

The Grav-Lox, according to CFIA, might be contaminated with Salmonella. Foodfest International 2000 Inc. (the distributor) recalled the offending product.

That was one month ago.

Today, CFIA rescinded its Health Hazard Alert, and advised the public that the Strubs Grav-Lox did NOT present a health risk from Salmonella.

Why the reversal? Because, according to CFIA, the lab responsible for reporting the initial Salmonella-positive result found that “...the Salmonella positive result was in fact a false positive, attributed to laboratory cross contamination.”

Now, I’ve worked in – and managed – several microbiology labs in my professional life. And I’m here to tell you that the LAST thing that should happen in a professionally run lab – whether government, in-house company, or third-party lab – is laboratory cross contamination.

Aseptic technique and assiduous attention to proper lab sanitation procedures are fundamental to the production of dependable lab results. So is the routine use of positive control and negative control sample analysis.

The company for whom the third-party lab did its analyses should have three questions for the lab’s management:

How did the lab cross-contamination happen?
Why did it take a full month for the cross-contamination to be discovered?
How will the lab change its procedures to ensure that the same thing doesn’t happen again?

I don’t know who hired the third-party lab; it could have been either Strubs or Foodfest (CFIA maintains its own labs). But, if I was the one who hired that hapless excuse for a professional lab, I’d be looking for a replacement, ASAP.

Botulism Alert – Finland, Germany, United Kingdom and USA

Italian olives tainted with botulinum toxin sickened two members of a Helsinki family last week.

Both individuals reported having eaten Gaudiano Organic Olives Stuffed with Almonds. Lab tests confirmed that the jar from which the two patients had eaten the olives contained botulinum toxin.

The tainted olives were packed in 314ml glass jars, with a best before date of 09/2012. They were imported into Finland by Kespro as early as September 2010. The olives were sold in Finland to K-food stores KCM Big Apple (Espoo), KCM Jumbo (Vantaa) and KSM South Centre (Rovaniemi), and to a few restaurants.

The olives have been withdrawn from sale in Finland, and consumers who purchased this product are asked to return it to the store.

Germany’s Federal Office for Consumer Protection and Food Safety has learned that some of these olives also were distributed in Germany, and is asking its citizens to dispose of any of the implicated jars of olives “with household waste”.

According to a notice posted October 21, 2011 on the Rapid Alert System for Foods and Feeds (RASFF) and updated this morning (October 24th), these olives also were distributed to the United Kingdom and the USA. So far, neither the U.S. Food and Drug Administration nor Britain’s Food Standards Agency has issued a Consumer Alert or a public health advisory of any sort.

eFood Alert Advisory to Consumers in Finland, Germany, the United Kingdom and the USA:

Check your pantry for Gaudiano Organic Olives Stuffed with Almonds (Product of Italy; Best before 09/2012), and discard the product in a safe manner. DO NOT TASTE THIS PRODUCT. If you have consumed even a tiny amount of this product and begin to experience any symptoms of botulism, including blurred vision or difficulty swallowing, seek immediate medical attention.

CooperVision Avaira® Toric Recall Goes Public

October 14, 2011.- Today – almost two months after issuing a “recall notification letter” to its US and Canadian distributors and health care practitioners, CooperVision’s recall notice finally appeared on FDA’s website.

The essential details of the formal recall notice are as follows:

Recall Class: Class I (Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.)
Date Recall Initiated: August 19, 2011
Product(s): AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. The lenses were manufactured from November 1, 2010 through August 3, 2011. Consumers wanting to determine whether their lot code was recalled can use the search box on the CooperVision recall web page at http://www.coopervision.com/recall or call the toll-free consumer hotline at 1-855-526-6737.
Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Please refer to the Recall Notice for additional information and instructions.

As I reported yesterday, FDA has received a total of 42 “adverse reaction” reports from contact lens wearers. Only 15 of those 42 reports were associated with Avaira® Toric contact lenses. According to FDA spokeswoman Morgan Liscinsky, several other brands manufactured by CooperVision have been the subject of consumer complaints, including Frequency 55 Toric, Proclear, Sofmed, and Enfilcon A contact lenses.

Several eFoodAlert readers also have reported eye discomfort and injuries associated with wearing Frequency 55 and Proclear contact lenses, in addition to many others who experienced corneal abrasions after wearing Avaira Toric lenses.

While I am pleased and relieved to see that CooperVision finally has consented to issue a Class I Recall Notice, I can’t help wondering whether this would have happened without the story published by JoNel Aleccia of msnbc.com on October 11th.

I also wonder how much more time must pass before CooperVision acknowledges that their problem extends beyond the Avaira Toric brand.