FDA warning letter
FDA Warns of Potential False Positive Results With Roche Cobas Liat Rapid SARS-CoV-2, Flu Test
The issues may relate to sporadically leaking assay tubes causing an obstructed optical path in the Cobas Liat analyzer or abnormal PCR cycling in the reaction tubes.
FDA Letter Warns About False-Positive Results From Becton Dickinson SARS-CoV-2 Test
The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test.
FDA Issues Warning Letter to Luminex
The firm said in an SEC document that it received an FDA warning letter in connection with the agency's requirements for its Verigene SP instrument.
HTG Molecular Warned by Nasdaq of Listing Non-Compliance
The firm received a notice from Nasdaq on Oct. 4 saying its stock had not met the minimum $1-per-share closing price requirement for 30 consecutive business days.
ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.