Yes – effective June 18, 2018, in cooperation with the FDA, Abbot Rapid Diagnostics (formerly Alere) ceased the distribution of Alere™ Influenza A&B Test – #412-000 (Test Product) and have requested their distribution partners do the same while they complete the clinical study described below. Alere has confirmed with FDA that healthcare providers can continue to use any Test Product that is currently in provider facilities.
FDA’s new requirements related to the reclassification of antigen-based rapid influenza detection test systems (RIDTs) took effect on January 12, 2018, at which time RIDTs were required to comply with new special controls (described in 21 CFR § 866.3328), including certain new minimum clinical performance criteria. Alere Scarborough, Inc. (Alere) has been communicating with FDA about the Test Product, and has continued to distribute the Test Product while evaluating the assay under the new minimum clinical performance criteria.
The clinical study conducted during the 2008-2009 respiratory season to support CLIA waiver for the Test Product included both prospectively collected nasal swab specimens and testing swab samples prepared with archived respiratory specimens. The performance assessment based on these data meets FDA’s new minimum clinical performance criteria. However, FDA subsequently informed Abbot Rapid Diagnostics (formerly Alere) that assessments of product performance relative to the new minimum clinical performance criteria should be conducted using only prospectively collected samples. Abbott Rapid Diagnostics is conducting a clinical study using only prospectively collected samples but have agreed, in consultation with FDA, to suspend distribution of the Test Product in the United States until we complete the study.