Accelerate PhenoTest BC Kit recallZ-0345-2023 · Accelerate Diagnostics Inc · initiated Oct 17, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Accelerate Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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]
Recall details
- Recall number
- Z-0345-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 17, 2022
- Posted by the FDA
- Dec 6, 2022
- Recalling firm
- Accelerate Diagnostics Inc
- Quantity
- 200 kits
- Product code
- PRH
- FDA submissions
- K192665
- 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, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates
Product description
Accelerate PhenoTest BC kit REF 10101018
Code information (models, lots, serial numbers)
Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Accelerate PhenoTest™ BC Kit 10101018Accelerate Diagnostics, Inc. · Positive Blood Culture Identification And Ast Kit1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91075).
- Z-0346-2023 · Open, ClassifiedAccelerate PhenoTest BC kit REF 10102018
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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