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U.S. Department of Health and Human Services

Class 2 Device Recall Biomeme SARSCoV2 Real Time RTPCR Test

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  Class 2 Device Recall Biomeme SARSCoV2 Real Time RTPCR Test see related information
Date Initiated by Firm October 20, 2021
Create Date January 04, 2022
Recall Status1 Terminated 3 on March 05, 2024
Recall Number Z-0452-2022
Recall Event ID 89064
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
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
Code Information All lots. Last lot of Kit distributed with the old IFU is 20210914.
Recalling Firm/
Manufacturer		 Biomeme, Inc.
1015 Chestnut St
Philadelphia PA 19107-4316
For Additional Information Contact Max Perelman
267-930-7707
Manufacturer 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).
FDA Determined
Cause 2		 Incorrect or no expiration date
Action On October 20, 2021, the firm sent an informal notice to customers titled "Product Update: Storing your RNA Process Control (RPC)". On November 4, 2021, the firm followed up with a formal notice titled "Medical Device Correction". The letter notified customers of the need to shorten the life of the RPC Buffer once resuspended from one week to TWO DAYS while stored at room temperature (15 degrees Celsius - 30 degrees Celsius). Actions to be taken by the Customer: Effective immediately, users of resuspended RPC Buffer should discard after two days when stored at room temperature. For longer-term storage, the RPC Buffer can be frozen once, at a temperature of -20¿C, for up to 3 months, and should not be frozen and thawed more than once. The expiration date of unopened RPC Kits will remain the same. Customers were also instructed to confirm receipt of the notification through a link provided by the firm. Customers should discard any other documents they may have on-hand that specifies the longer shelf-life stated in the IFU. When available, Biomeme will deliver updated versions of the IFU to all users by email.
Quantity in Commerce 11,607
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.
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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