Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-S
Summary
The FDA issued a Class II for Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100 by Biomeme, Inc.. 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 hav.
Details
Source
Device Recall
External ID
Z-0452-2022
Action Date
2022-01-12
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: All lots. Last lot of Kit distributed with the old IFU is 20210914.
Quantity Affected: 11,607
Reason for Recall
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).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-20
Company
Philadelphia, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomeme, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomeme, Inc. have FDA actions?
This is the only FDA action we have on record for Biomeme, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0452-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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