DiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
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…
Read the official notice →- Date
- 2022-01-12
- Country
- United States
- Brand
- DiaSorin Molecular
- Product
- Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
- Classification
- Class II
- Units
- US: AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More DiaSorin Molecular recalls
- 2023-07-26
USDiaSorin Molecular LLC recalls Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct…
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
FDA · DeviceDiaSorin Molecular LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2023-03-15
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DiaSorin Molecular LLC recalls Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
FDA · DeviceDiaSorin Molecular LLCUS Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL,…Official notice → - 2021-10-27
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DiaSorin Molecular LLC recalls SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
FDA · DeviceDiaSorin Molecular LLCWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice →
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- 2022-01-12
- US
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Tapemark Company recalls iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch…
The dosage information on the pouch is incorrect; the primary carton label is correct.
FDA · DeviceTapemark CompanyUS Nationwide distribution in the states of CA, FL, IL, MO, NY, OH, and TN.Official notice →