--- title: "Accelerate Diagnostics Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Accelerate Diagnostics Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/accelerate-diagnostics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Accelerate Diagnostics Inc recall records **2** reported ongoing 2 records in this archive. Latest source date Oct 17, 2022. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Oct 17, 2022 FDA device enforcement ### [Accelerate PhenoTest BC kit REF 10101018](https://isitonrecall.com/recall/fda-device-z-0345-2023-accelerate-phenotest-bc-kit-ref-10101018/) 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. Class II Reported ongoing Distribution: U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Pol... [Official source for Accelerate PhenoTest BC kit REF 10101018](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0345-2023%22) Oct 17, 2022 FDA device enforcement ### [Accelerate PhenoTest BC kit REF 10102018](https://isitonrecall.com/recall/fda-device-z-0346-2023-accelerate-phenotest-bc-kit-ref-10102018/) 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. Class II Reported ongoing Distribution: U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Pol... [Official source for Accelerate PhenoTest BC kit REF 10102018](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0346-2023%22) ## Reasons in these listed records - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Accelerate Diagnostics Inc ### Is there a recall on accelerate diagnostics inc right now? This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Accelerate Diagnostics Inc](https://isitonrecall.com/check/?q=Accelerate%20Diagnostics%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)