Z-0345-2023Class II

Accelerate PhenoTest BC kit REF 10101018

Name: Z-0345-2023 Accelerate PhenoTest BC kit REF 10101018
Creator: Accelerate Diagnostics Inc
Published: 2022-10-17
License: https://open.fda.gov/license/

Accelerate Diagnostics, Inc. / initiated 2022-10-17 / Open, Classified

FDA source

Accelerate Diagnostics Inc began a recall of Accelerate PhenoTest BC kit REF 10101018 on 2022-10-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0345-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-17
Posted: 2022-12-06
Recalling firm: Accelerate Diagnostics, Inc.
Product: Accelerate PhenoTest BC kit REF 10101018
Product code: PRH Positive Blood Culture Identification And Ast Kit
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.
FDA root cause: Mixed-up of materials/components
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]
Quantity in commerce: 200 kits
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 codes and lots: Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0345-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0345-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-30
Z-0346-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-30

Product code PRH

K192665Class IIAccelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. / cleared 2020-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)