Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box c

FDA device recall Z-2153-2023 · posted 2023-07-18 · Open, Classified

Recall details

Recalling firm

DiaSorin Molecular LLC

Reason for recall

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

Action taken

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 technicalinfo.molecular@DiaSorin.com. 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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OOI

Quantity affected

4,7878 units

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

Date initiated

2023-06-14

Date posted

2023-07-18

Location

Cypress, CA