Biomeme SARS-CoV-2 Test Instructions Recall: Incorrect Buffer Shelf-Life
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a labeling error in product instructions—the specified shelf-life for resuspended buffer is one week when stability studies show it is only two days. If users follow the incorrect instructions, they may employ degraded buffer material, which could compromise test accuracy.
Plain-English summary
Biomeme, Inc. is recalling the Instructions for Use (IFU) for the Biomeme SARS-CoV-2 Real Time RT-PCR Test (Part Number 100002824), a component of SARS-CoV-2 Go-Strips, Go-Plates, and Bulk Vials. A total of 11,607 units were distributed to laboratories and healthcare facilities across 16 U.S. states and internationally to Ghana, Dominican Republic, and Singapore.
The current Instructions for Use specify that the RPC Buffer, once resuspended, remains stable for one week when stored at room temperature (15–30°C). However, FDA-reviewed stability studies have determined that resuspended RPC Buffer is stable for only two days under these storage conditions. Use of buffer beyond this timeframe may result in degraded material that affects test accuracy.
This recall affects all lots manufactured, with the last lot containing the original instructions distributed on September 14, 2021. Healthcare facilities, laboratories, and testing sites that received this product should review the corrected instructions from Biomeme.
The recalled product
- 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
- Manufacturer
- Biomeme, Inc.
- Hazard
- incorrect-instructions
- diagnostic-accuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots. Last lot of Kit distributed with the old IFU is 20210914.
Distribution
Distributed in 16 states:
- AZ
- CA
- FL
- HI
- IN
- KY
- MD
- MO
- NC
- NJ
- NY
- OH
- OK
- PA
- TX
- VA
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