Accelerate PhenoTest BC Kit recallZ-0346-2023 · 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-0346-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 17, 2022
- Posted by the FDA
- Dec 6, 2022
- Recalling firm
- Accelerate Diagnostics Inc
- Quantity
- 7,160 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 10102018
Code information (models, lots, serial numbers)
Part Number: 10102018 UDI-DI Code: 00862011000369 Lot Numbers: 5559A 5556A 5555A 5554A 5553A 5551A 5550A 5548A 5546A 5557A 5558A 5560A 5561A 5562A 5563A 5564A 5567A 5568A 5570A 5571A 5572A 5574A 5578A 5579A 5580A 5583A 5577A 5576A 5581A 5582A 5585A 5586A 5587A 5589A 5590A 5591A 5592A 5594A 5595A 5596A 5597A 5598A 5599A 5601A 5602A 5603A 5604A 5607A 5608A 5610A 5611A 5613A 5614A
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 10102018Accelerate Diagnostics, Inc. · Positive Blood Culture Identification And Ast Kit1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 91075).
- Z-0345-2023 · Open, ClassifiedAccelerate PhenoTest BC kit REF 10101018
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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