Laboratory kits testing for Herpes Simplex Virus 1 and 2 and Group A Strep have been recalled. These kits may potentially give inaccurate results, which may lead to an improper medical diagnosis.
The FDA has issued a Class I recall for faulty test kits produced by Focus Diagnostics. This is the most serious kind of recall. Customers who may have ordered and used defective kits should discontinue use immediately.
“Class I recalls are potentially life-threatening. These types of recalls are rare, but urgent,” said Bogdan Martinovich, a Lake County personal injury attorney. “A Class I recall is designed to ensure that the product is removed from the market and the company involved is in compliance.”
What is being recalled?
Certain laboratory kits testing for Herpes Simplex Virus 1 and 2 and Group A Strep are being recalled. These kits may have faulty lamination between sample wells. Fluids could leak out of the initial testing well into an adjacent well. This could potentially cause cross-contamination. Results from faulty test kits may not be reliable as samples from different patients could get mixed up.
Focus Diagnosis is part of the Quest Diagnosis family. The component that is defective was manufactured by 3M. The faulty kits were made between July 2015 to February 2016. Over 1600 tests are affected by the recall.
Why could this be dangerous?
A Class I recall was issued because of the risk of severe injury or death. The faulty test kits could give false positives, false negatives or invalid results. Inaccurate results may cause patients to be incorrectly diagnosed. This would also lead to improper treatment, causing adverse health consequences and possibly death.
According to Lake County personal injury attorney Bogdan Martinovich, “These defective kits were sold and used in Illinois. Anyone who has received a diagnosis using these kits should be reevaluated.”