FDA Medical Device Recalls (openFDA)
DiaSorin Molecular LLC: SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
- Recall number
- Z-0162-2022
- Recalling firm
- DiaSorin Molecular LLC
- Product
- SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
- Status
- Open, Classified
- Initiated
- 2021-09-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
- Root cause
- Process control
- Action
- On September 23, 2021, DiaSorin Molecular issued a field courtesy notification letter via email. On October 18, 2021, DiaSorin issued a "Urgent: Medical Device Correction" notification to provide additional details concerning the recall. In addition to informing consignees about the correction, DiaSorin asked consignees to take the following actions: 1. A run with a failed positive control should be repeated per the IFU instructions. 2. Please be sure to notify others within your network that may have received these kits. 3. Please complete and return the Acknowledgement and Receipt Form (page 2) of this notification letter. 4. 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 us. 5. If you have any questions or if you have experienced an invalid Positive Control run and would like replacement product for the tests that were invalid due to this, please contact DiaSorin Molecular Technical Service, Mon-Fri, 7:00 AM to 5:00 PM (Pacific Time) at (800) 838-4548, option 3, or by email at ts.molecular@DiaSorin.com. 6. 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.
- Quantity
- 1690 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Italy.
- Lot, serial or model codes
- Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 2023365
- Firm city
- Cypress
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28