Microbiologics Inc: Medical Device Recall in 2021 - (Recall #: Z-2487-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SARS-CoV-2 Process Control (Swab) - 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.

Product Classification:

Class II

Date Initiated: August 20, 2021

Date Posted: September 29, 2021

Recall Number: Z-2487-2021

Event ID: 88578

Reason for Recall:

The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences.

Status: Terminated

Product Quantity: 127

Code Information:

Catalog # HE0063S Lot #'s: HE0063-100-1, HE0063-103-2, HE0063-103-3, HE0063-103-1, HE0063-104-1, HE0063-101-1 and HE0063-100-1.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IL, MD, MT, MN, NC, NY, NV, OR, TN, TX,UT, WA and WI. The countries of Austria, Canada, Colombia, France, Germany, Hong Kong, India, Ireland, Italy, Japan and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated