Summary
The FDA issued a Class II for Accelerate PhenoTest BC kit REF 10102018 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-0346-2023
Action Date
2022-12-07
Status
Ongoing
Category
device
Product Description
Accelerate PhenoTest BC kit REF 10102018
Lot/Code Info: 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
Quantity Affected: 7,160 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-0346-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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