Agency classClass IIOur severity:High FDA (Devices)·Z-0457-2022·Announced 2022-01-12

Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination

DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with theoretical risk of sample cross-contamination in laboratory settings. No illnesses or injuries are mentioned in the source. This is a risk-of-harm product without reported harm, meeting the 'High' (3) severity criterion.

Plain-English summary

DiaSorin Molecular LLC is recalling the Simplexa Direct Amplification Disc Kit (Product Kit Code MOL1455). The kit is used with Simplexa COVID-19 Direct and Simplexa Flu A/B & RSV Direct Gen II testing systems. Approximately 29,495 kits have been distributed.

A subset of the affected discs are at risk of leakage when used more than once. If leakage occurs from a well containing a positive sample, it may cause cross-contamination in laboratory areas, potentially affecting the accuracy of test results if the area is not properly cleaned.

The affected kits have been distributed throughout the United States and internationally, including Kuwait, Australia, Israel, Italy, Canada, Chile, Puerto Rico, and the United Arab Emirates. Specific lot numbers are identified in FDA documentation.

Consumers (healthcare facilities and laboratories) should refer to DiaSorin Molecular's guidance for instructions on checking lot numbers and properly handling affected kits.

The recalled product

Product: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Manufacturer: DiaSorin Molecular LLC
Category: Medical Device — Molecular Diagnostic Kit
Hazard: device-leakage
cross-contamination
Affected units: 29,495

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

12411N (12147N)
12413N (12149N)
12477N (12150N)
12602N (11548NA)
12603N (12144N)
12721N (12148N)
12889N (12151N)
13369N (12817N)
13370N (13151N)
13434N (12382N)
13652N (12835N)

Distribution

Distributed in 41 states:

Same manufacturer · DiaSorin Molecular LLC

See all →

High
Simplexa Direct Amplification Disc Kit recalled for potential liquid spillage
FDA (Devices) · 2023-07-26
High
Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components
FDA (Devices) · 2023-03-15
High
COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results
FDA (Devices) · 2023-03-15
High
COVID-19 Diagnostic Control Pack Recalled for Unapproved Raw Materials
FDA (Devices) · 2021-10-27
High
DiaSorin Simplexa HSV 1&2 Direct Recalled Due to Software Malfunction
FDA (Devices) · 2020-07-22

Same hazard · device leakage