Z-0162-2022Class II

SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

Name: Z-0162-2022 SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Creator: DiaSorin Molecular LLC
Published: 2021-09-23
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2021-09-23 / Open, Classified / root cause: manufacturing process

FDA source

DiaSorin Molecular LLC began a recall of SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 on 2021-09-23. FDA classified it as Class II and gives the reason as "Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0162-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-23
Posted: 2021-10-21
Recalling firm: DiaSorin Molecular LLC
Product: SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: Lot #/Expiration Date: 12175N/11.30.2021, 12722N/01.31.2022, X12122N/01.31.2022, X12724N/08.31.2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0162-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-21

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)