Diagnostic Test Developer bioMérieux Receives FDA Class I Recall
The FDA along with bioMérieux recommend that laboratory personnel discuss previously conducted tests and their respective results with each institution’s Laboratory Medical Director to determine next steps.
January 6, 2016 | by Sarah Massey, M.Sc.
Just before the end of 2015, France-based antibiotic test developer, bioMérieux, received notice that their diagnostic tests would be subject to a US Food and Drug Administration (FDA) Class I recall due to the risks that the tests could produce false positives. bioMérieux’s Etest PIP/TAZO/CON-4 PTC 256 is used to determine if a specific antibiotic treatment – known as Piperacillin/Tazobactam (PIP/TAZO) – will be effective if used to treat patients with serious infections.
The company recalled the tests because they may indicate that PIP/TAZO treatment could slow the growth or completely stop an infection, when that might not be the case. This risk of getting a false positive when using the diagnostic test could result in the ineffective treatment of a patient’s infection, potentially leading to a lengthened hospital stay, failure of the treatment to produce results, sepsis, and in some instances, death.
On November 24, 2015, bioMérieux sent an Urgent Product Removal notice to its customers urging them to discontinue use of any of the effected tests, and ensure all laboratory personnel are aware of the issue. According to the Recall Notice issued by the FDA, affected products include those with manufacturing dates between December 20, 2012 and October 23, 2015.
The FDA along with bioMérieux recommend that laboratory personnel discuss previously conducted tests and their respective results with each institution’s Laboratory Medical Director to determine next steps. Customers of bioMérieux are also asked to confirm their receipt of the recall notice by completing and submitting the Acknowledgement Form.
The recall comes just a few weeks after the company announced the launch of a genomic sequencing service for patient bacterial infections. The EpiSeq service allow healthcare providers to better diagnose and characterize bacterial infections, and was created alongside next-generation sequencing (NGS) partner, Illumina.
“We are proud to partner with bioMérieux to bring this first-of-its-kind offering to market,” said Jay Flatley, CEO of Illumina, in a statement regarding the collaboration. “NGS can be used to better characterize and understand infection-causing bacteria on a whole genome basis. With the growth of antibiotic resistant strains, this unique offering couldn't be more timely or important to the future of public health.”
Jean-Luc Belingard, chairman of bioMérieux, said, “We are very pleased to be the first company to offer our customers an innovative sequencing solution in bacterial epidemiology. The bioMérieux EpiSeq service addresses major public health challenges, combatting infectious diseases and resistance to antibiotics.”
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Keywords: Diagnostic Test, Antibiotic, FDA
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