Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 bo
Summary
The FDA issued a Class II for Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Ampl by DiaSorin Molecular LLC. Reason: There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc..
Details
Source
Device Recall
External ID
Z-2153-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452
Lot/Code Info: MOL1455 UDI-DI: 01-30816101025092 MOL1455 kit lot codes: P17044N P17052N P17301N P17302N P17303N P17304N P17305N P17306N P17351N P17352N P17353N P17354N P17614N P17625N P17650N P17652N P17653N P17654N P17687N P17688N P17731N MOL1452 disc lot codes: P15886N P16794N P16795N P16796N P16883N P16885N P17022N P17056N P17057N P17047N P17023N P17176N P17177N P17294N P17178N P17295N P17359N P17362N P17296N P17361N P17046N
Quantity Affected: 4,7878 units
Reason for Recall
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-14
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 192 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-2153-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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