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
- Company
- Diasorin Molecular Llc
- Recall Initiated
- June 14, 2023
- Posted
- July 18, 2023
- Recall Number
- Z-2153-2023
- Quantity
- 4,7878 units
- Firm Location
- Cypress, CA
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.
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
Root Cause
Under Investigation by firm
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