FDA Medical Device Recalls (openFDA)
Biomeme, Inc.: Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
- Recall number
- Z-0452-2022
- Recalling firm
- Biomeme, Inc.
- Product
- Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564
- Status
- Terminated
- Initiated
- 2021-10-20
- Posted
- not on file
- Terminated
- 2024-03-05
- Reason
- 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).
- Root cause
- Incorrect or no expiration date
- Action
- On October 20, 2021, the firm sent an informal notice to customers titled "Product Update: Storing your RNA Process Control (RPC)". On November 4, 2021, the firm followed up with a formal notice titled "Medical Device Correction". The letter notified customers of the need to shorten the life of the RPC Buffer once resuspended from one week to TWO DAYS while stored at room temperature (15 degrees Celsius - 30 degrees Celsius). Actions to be taken by the Customer: Effective immediately, users of resuspended RPC Buffer should discard after two days when stored at room temperature. For longer-term storage, the RPC Buffer can be frozen once, at a temperature of -20C, for up to 3 months, and should not be frozen and thawed more than once. The expiration date of unopened RPC Kits will remain the same. Customers were also instructed to confirm receipt of the notification through a link provided by the firm. Customers should discard any other documents they may have on-hand that specifies the longer shelf-life stated in the IFU. When available, Biomeme will deliver updated versions of the IFU to all users by email.
- Quantity
- 11,607
- 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.
- Lot, serial or model codes
- All lots. Last lot of Kit distributed with the old IFU is 20210914.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3014117298
- Firm city
- Philadelphia
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28