The FDA slapped French molecular diagnostics company bioMérieux with a Class I recall over tests used to predict whether a certain antibiotic will be useful in treating serious bacterial infections, a thorn in the company's side as it continues to make progress with infectious disease testing initiatives and product development.
bioMérieux told customers in November that it would recall 3,760 of its Etest PIP/TAZO/CON-4 PTC 256 tests because the products might incorrectly show that an antibiotic, PIP/TAZO, slows or stops bacteria from growing. The error could result in incorrect treatment and other problems for patients, including increased hospital stays, unnecessary tests or procedures, sepsis and in some cases, death. The recall applies to all tests manufactured between Dec. 20, 2012, and Oct. 23, 2015, and also those products distributed between Jan. 24, 2013 and Nov. 9, 2015, the FDA said in its notice.
In the meantime, bioMérieux is urging customers to review its notification and alert lab personnel about the recall, to stop using the tests and to get rid of any remaining inventory. The company also wants customers to discuss concerns about previously reported test results with a Laboratory Medical Director, forward questions about the recall to its customer care center and fill out an acknowledgment form to confirm that they saw the safety notice, it said in a statement.
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| Illumina CEO Jay Flatley |
The news comes a few weeks after bioMérieux launched a whole genome sequencing service with diagnostics giant Illumina ($ILMN), delivering the fruits of an almost yearlong labor to develop a product that could improve infectious bacterial disease monitoring and control hospital-acquired infections. The companies' bioMérieux EpiSeq service draws on Illumina's next-generation sequencing (NGS) tech and bioMérieux's collection of bacterial cultures to help hospitals see how bacteria are transmitted and potentially reduce epidemics.
"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," Illumina CEO Jay Flatley said at the time.
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