Summary
The FDA issued a Class II for Accelerate PhenoTest BC kit REF 10101018 by Accelerate Diagnostics Inc. Reason: Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results.
Details
Source
Device Recall
External ID
Z-0345-2023
Action Date
2022-12-07
Status
Ongoing
Category
device
Product Description
Accelerate PhenoTest BC kit REF 10101018
Lot/Code Info: Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A
Quantity Affected: 200 kits
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-17
Company
Tucson, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Accelerate Diagnostics Inc has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accelerate Diagnostics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accelerate Diagnostics Inc have FDA actions?
Accelerate Diagnostics Inc has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0345-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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