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Simplexa Direct Amplification Disc Kit, Rx Only, IVD recallZ-2153-2023 · DiaSorin Molecular LLC · initiated Jun 14, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DiaSorin Molecular LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

FDA root cause category: Under Investigation by firm

What the company is doing

On June 19, 2023 DiaSorin Molecular issued a "urgent: Medical Device Correction Notification to affected consignees via E-Mail. DiaSorin Molecular asked consignees to take the following actions: 1. Any remaining discs in inventory that are listed in the table below should be discarded. Replacement will be provided. 2. Any sample with an error code should be retested. 3. If leakage is suspected, the spillage should be removed, and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. 4. Notify others within your network that may have received these kits. 5. Complete and return the Acknowledgement and Receipt Form (page 3) of this notification letter. 6. If your firm has further distributed the devices, please share a copy of this correction notification and response form with those customers and provide a copy of the completed response form back to us. 7. If you have any questions, and to request material replacement, please contact DiaSorin Molecular Technical Service, Monday Friday, 7:00am to 5:00pm (Pacific Time) at (800) 838-4548, option 3, or by email at [email protected]. 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax

Recall details

Recall number
Z-2153-2023
Status
Open, Classified
Initiated by the company
Jun 14, 2023
Posted by the FDA
Jul 18, 2023
Recalling firm
DiaSorin Molecular LLC
Quantity
4,7878 units
Product code
OOI
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.

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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