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MPL Laboratories
12 Wilson Drive
Sparta, NJ 07871

Phone: 973-300-9715
A Full Service Microbiology Laboratory


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Pharmaceutical Testing Services

Category Press Release
Publish Date 7/13/2023
Author Paul Cochrane
Title FDA Warns Consumers Not to Use Certain COVID-19 At-Home Tests Due to Bacterial Contamination Concerns
Introduction MPL Laboratories provides microbial and sterility testing services for test kits, over-the-counter (OTC) medicines, pharmaceuticals, cosmetics and other consumer products to protect the public and to help prevent costly recalls.
Sparta, New Jersey, July 13, 2023 

Last month, the U.S. Food & Drug Administration (FDA) warned consumers and health care providers to stop using and throw out certain lots of a brand of COVID-19 at-home test kits. The FDA reported the agency has significant concerns of bacterial contamination in the liquid buffer solution that is provided in the test kit. The company that manufactured the kits has also warned consumers not to use them and announced a recall of over 500,000 test kits. 

According to the FDA, the liquid solution provided in the affected test kits has been found to be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species. Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid buffer when opening or handling the tube, or while performing the test. 

Health care providers are also being advised by the FDA that if a patient presents with signs of bacterial infection, such as fever, conjunctivitis, or other signs or symptoms of systemic infection, they should consider whether the patient has recently used one of the affected test kits. If they have, health care providers should consider whether their infection may be from exposure to the contaminated buffer solution. 

Dedicated to protecting consumers and preventing these types of costly recalls are the scientists at MPL Laboratories. Their FDA registered and DEA licensed testing facility offers cGMP and ISO 17025 compliant sterility and microbiology testing of test kits, OTC medicines, pharmaceuticals, cosmetics, personal care products and other consumer products. 

To learn more about product testing or other analytical services provided by MPL Laboratories, please visit, call (800) 548-1874 or email

About MPL Laboratories
MPL Laboratories (formerly Marypaul Laboratories) was founded in 1985 as a full-service microbiology laboratory. It is cGMP compliant, FDA and DEA registered, ISO/IEC 17025 accredited by PJLA, and NJDEP certified. MPL’s staff includes M.S. and B.S. degreed microbiologists and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, cosmetic, personal care and food industries. MPL aims to provide its clients with high quality, reliable test data in a timely manner. The laboratory is part of the EMSL Analytical, Inc. network of laboratories across the United States and Canada. 
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