Reported Jan 12, 2022 · Terminated
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2…
Biomeme, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomeme, Inc. · 1015 Chestnut St · Philadelphia, PA · 19107-4316
Is this the product you have?
- Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use
- Part number 100002824 Subcomponent of
SARS-CoV-2 Go-Strips3000555SARS-CoV-2 Go-Plates3000562SARS-Cov-2 Bulk Vials3000564
- Lot codes and dates
- All lots. Last lot of Kit distributed with the old IFU is 20210914.
- Amount recalled
- 11,607
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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