medical Class II Updated 2021-09-29

Microbiologics Inc recalls SARS-CoV-2 Process Control (Pellet) - Product Usage: intende

Recalled Product

SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

Hazard / Issue

The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog # HE0062S Lot #'s: HE0062-01-1, HE0062-01-2, HE0062-03-1, HE0062-04-1, HE0062-04-2, HE0062-05-1, HE0062-05-2, HE0062-06-1 and HE0062-06-2
View official government recall

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