Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Accelerate PhenoTest BC kit REF 10102018 Recalled by Accelerate Diagnostics Inc Due to Due improperly formulated and released bulk lot of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accelerate Diagnostics Inc directly.
Affected Products
Accelerate PhenoTest BC kit REF 10102018
Quantity: 7,160 kits
Why Was This Recalled?
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
Where Was This Sold?
This product was distributed to 31 states: AR, CA, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MN, MS, MO, MT, NJ, NY, NC, ND, OH, PA, RI, SC, TN, TX, VA, WA, WV, DC
About Accelerate Diagnostics Inc
Accelerate Diagnostics Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report