Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination

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

Is your product affected?

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

Distribution

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