Abbott Laboratories has recalled a specific production lot of its BinaxNOW rapid strep test kits after internal quality testing revealed the kits were producing false negative results at a rate significantly above acceptable thresholds. The affected lot, distributed to urgent care clinics and pharmacies across 28 states, contained approximately 620,000 individual test kits.
The company determined that a reagent concentration issue during manufacturing caused the test's sensitivity to drop below 70 percent, compared to the validated sensitivity of 95 percent. Healthcare providers using tests from the recalled lot may have sent patients home without appropriate antibiotic treatment for Group A Streptococcus infections.
Abbott is notifying affected distribution partners directly and urging providers to retest any patients who received negative results from the recalled lot within the past 30 days. Replacement kits are being shipped on an expedited basis.
