DiaSorin Molecular LLC 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
DiaSorin Molecular LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
DiaSorin Molecular LLC is recalling Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, RE due to There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026