Lower riskMedical device recall · FDA · Published October 20, 2021
Biomeme SARS-CoV-2 Test Kits: Shorter Buffer Shelf Life Needed
Biomeme recalls SARS-CoV-2 test kits with shorter RPC Buffer shelf life. The buffer stabilizes for two days instead of one week at room temperature. No action needed for users.
The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).
Take action
Contact the company
📍Recalling firmBiomeme, Inc.1015 Chestnut St · Philadelphia, PA 19107-4316
“Biomeme SARS-CoV-2 Test Kits: Shorter Buffer Shelf Life Needed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61653-biomeme-sars-cov-2-test-kits-shorter-buffer-shelf-life. Based on FDA recall #Z-0452-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0452-2022%22&limit=1).
The FDA announced on 2021-10-20 that Biomeme, Inc. voluntarily recalled its SARS-CoV-2 Real Time RT-PCR Test Instructions for Use, Part number 100002824. The hazard involves an incorrect shelf-life specification for the RPC Buffer after resuspension.
How to tell if you have it
Brand: Biomeme
Product: SARS-CoV-2 Real Time RT-PCR Test, Instructions for Use
The Instructions for Use currently specify a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies indicate this period must be shortened to two days when stored at room temperature (15degC-30degC).
Context
GovInfoNow's records show Biomeme, Inc. has two other recalls on record since 2020-10-23. On 2021-01-05, the company recalled nucleic acid test devices that may not work due to a software error causing instrument failure. On 2020-10-23, Biomeme issued a recall for SARS-CoV-2 tests that may give false positives due to a software issue.
How to tell if you have this one
Check for part number 100002824 on the test kit. All lots are affected, with the last kit distributed using the old instructions on September 14, 2021.
Brand
Biomeme
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Buffer Shelf Life
The buffer stabilizes for two days instead of one week at room temperature. No action is needed for users.
Where it went and when
Where it was distributed
Distributed in 16 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA. Foreign distribution to Ghana, Dominican Republic, and Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Hawaii, Indiana, Kentucky, Maryland, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0452-2022 (October 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0452-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.