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U.S. Department of Health and Human Services

Class 3 Device Recall Biomeme SARSCoV2 test

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  Class 3 Device Recall Biomeme SARSCoV2 test see related information
Date Initiated by Firm January 05, 2021
Create Date February 01, 2021
Recall Status1 Terminated 3 on June 11, 2021
Recall Number Z-0940-2021
Recall Event ID 87153
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product 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.
Code Information Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3  EUA - Emergency Use Authorization
Recalling Firm/
Manufacturer		 Biomeme, Inc.
1015 Chestnut St
Philadelphia PA 19107-4316
For Additional Information Contact Andrew Barnard
267-930-7707
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action On 01/05/2021 Biomeme, Inc., issued an Urgent Device Recall Correction for the latest build of the Franklin Real-Time PCR Thermocycler, which affects some devices built since September 21st, 2020. This software correction is to fix an issue where the device is unable to get past the beginning stages of the test.
Quantity in Commerce 147 systems
Distribution Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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