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Biomeme, Inc. Recall 89064

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

Biomeme, Inc. Recall 89064 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0452-2022
Event ID89064
Event DescriptionBiomeme 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
Product TypeDevices
DistributionDomestic 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.
Quantity11,607
Recall ReasonThe 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).
Device Classification20220112
Device Code InfoAll lots. Last lot of Kit distributed with the old IFU is 20210914.
Center Classification Date20220104
Recall Initiation Date20211020
Recalling FirmBiomeme, Inc.
Initial Notification Letter
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