Accelerate PhenoTest BC kit REF 10101018
Reported: December 7, 2022 Initiated: October 17, 2022 #Z-0345-2023
Product Description
Accelerate PhenoTest BC kit REF 10101018
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.
Details
- Recalling Firm
- Accelerate Diagnostics Inc
- Units Affected
- 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
- Location
- Tucson, AZ
Frequently Asked Questions
What product was recalled? ▼
Accelerate PhenoTest BC kit REF 10101018. Recalled by Accelerate Diagnostics Inc. Units affected: 200 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2022. Severity: Moderate. Recall number: Z-0345-2023.
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