Accelerate Diagnostics Inc: Medical Device Recall in 2022 - (Recall #: Z-0345-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Accelerate PhenoTest BC kit REF 10101018

Product Classification:

Class II

Date Initiated: October 17, 2022

Date Posted: December 7, 2022

Recall Number: Z-0345-2023

Event ID: 91075

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.

Status: Ongoing

Product Quantity: 200 kits

Code Information:

Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

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

Voluntary or Mandated:

Voluntary: Firm initiated