Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Biomeme, Inc.
- Reason for Recall:
- Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.
Product Codes/Lot Numbers:
Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization
Distribution:
Distributed in: FL, TX, IN, KY, OH, NY, CA, PA, MD
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0940-2021
Related Recalls
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).
The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.