Life Technologies Gets Form 483 for Reporting Failures, Quality Issues
Life Technologies, a manufacturer of biomedical products, was handed a Form 483 for failing to submit timely MDRs after erroneous results from some of its tissue-typing kits.
The Jan. 20 form, delivered to the company's Brown Deer, Wis., offices, says the company failed to comply with the FDA's 30-day timeframe when reporting false negative results from HLA typing test kits. These could cause tissue-typing errors for potential organ recipients and donors, the form says.
Complaints of false negatives in June 2014 were followed by MDRs 60 days after the results were confirmed, the form says. Inconsistencies in testing identified in September 2013, which could result in mistyping, were not reported until 78 days later.
Life Technologies performed two correction and removal actions for DNA-based HLA typing kits but failed to report the number of affected kits to the FDA. Mistyped results could potentially result in the transplant of an organ that is unknowingly not as compatible as it should be, or potentially rule out consideration of a patient or an organ for transplant, the form says.
Another observation notes the firm failed to prevent distribution of a particular lot of mislabeled kits identified in July 2014. Read the 483 at www.fdanews.com/03-17-15-Lifetech.pdf.