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Open, Classified

Accelerate PhenoTest BC kit REF 10102018

FDA Recall Z-0346-2023 · Posted 2022-12-06

Recalling FirmAccelerate Diagnostics Inc
Recall StatusOpen, Classified
Product CodePRH
Date Initiated2022-10-17
Product Quantity7,160 kits

Reason for Recall

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.

Firm Action

On 11/04/2022, the firm communicated an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that the firm has become aware of complaints concerning false positive identification results for Staphylococcus aureus and Streptococcus spp. when using the Accerlerate PhenoTest BC kits. Customer are instructed to: (1) Share this customer notification with all who need to be made aware within their organization. (2) Appropriately destroy all affected Accelerate PhenoTest BC kits by defacing all labeling and disposing in accordance with site biohazard or waste policies and procedure. (3) Complete the Recall Response Form and return it to Accelerate Diagnostics. (4) Retrospectively review runs from affected lots, specifically those runs with positive identification results for either Staphylococcus aureus or Streptococcus spp. Follow their institutional policies and processes to review prior patient results related to the described issue. (5) Continue to report all technical issues through Accelerate Technical Support. Contact for Questions: NA Customer Service & Technical Support Toll free: +1 (888) 586 2939 opt. 4 Direct: +1 (520) 365 3100 Email: [email protected]

Root Cause

Mixed-up of materials/components

Distribution Pattern

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, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192665Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. · 2020-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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