Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Summary
The FDA issued a Class II for Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 by DiaSorin Molecular LLC. Reason: A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direc.
Details
Source
Device Recall
External ID
Z-0457-2022
Action Date
2022-01-12
Status
Ongoing
Category
device
Product Description
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Lot/Code Info: Kit Product Code MOL1455 (UDI 01-30816101025092) contains 3 discs with Disc Product Code MOL1452. Below lists the MOL1455 Kit Lot numbers (and MOL1452 Disc Lot Numbers): 12410N (12152N), 12411N (12147N), 12413N (12149N), 12477N (12150N), 12602N (11548NA), 12603N (12144N), 12721N (12148N), 12889N (12151N), 13369N (12817N), 13370N (13151N), 13434N (12382N), 13652N (12835N), and 13242N (12154N)*. *Kit Lot #13242N (Disc Lot #12154N) was shipped to Europe and not within the US.
Quantity Affected: 29495 kits
Reason for Recall
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Distribution
US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV; and Worldwide: Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-19
Company
Cypress, CA
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 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DiaSorin Molecular LLC has 11 FDA actions in our database, including 5 recalls and 6 clearances.
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 (DiaSorin Molecular LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DiaSorin Molecular LLC have FDA actions?
DiaSorin Molecular LLC has 11 FDA actions in our database, including 5 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0457-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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