MPORTANT: BinaxNOW™ COVID-19 – Product Expiry Update

DHS Logo Original 07/11/2018

Division of Quality Assurance: Notifications & Updates

Attn: Nursing Home and Assisted Living Providers

MPORTANT: BinaxNOW™ COVID-19 – Product Expiry Update

Abbott recently released a BinaxNOW™ COVID-19 Product Expiry Update informing testing sites that the expiration dates of certain kit lots have been extended to allow for their use past the labeled expiration dates.

Do not separate BinaxNOW™ kit components from their kit box. The lot numbers of the kit components (cards and drops) do not match the lot numbers of the BinaxNOW™ kit (set of 40 tests in a box).

If the kit components are removed from the kit box, it is no longer possible to determine if their expiration date has been extended. This could happen if the components are kept separate from the box or if a few remaining cards or drops are transferred into a new kit box.

If components are separated from their kit, you may write the new expiration date on the components. Otherwise, you should use the expiration dates printed on the components.

The risk is that expired materials could be used for patient testing, which could lead to inaccurate results. Use of expired reagents is prohibited in the federal CLIA (Clinical Laboratory Improvement Amendments) regulations and can lead to possible deficiencies, which may result in enforcement or sanction actions. Facilities that believe they may have used expired reagents should contact patients to inform them their test results may be inaccurate and to recommend retesting.

If you have questions regarding this information, please contact the COVID Testing Task Force at