Z-0452-2022Class II

Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of...

Name: Z-0452-2022 Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of...
Creator: Biomeme, Inc.
Published: 2021-10-20
License: https://open.fda.gov/license/

Biomeme, Inc. / initiated 2021-10-20 / Terminated / root cause: labeling and UDI

FDA source

Biomeme, Inc. began a recall of 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... on 2021-10-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0452-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-20
Posted: 2022-01-04
Terminated: 2024-03-05
Recalling firm: Biomeme, Inc.
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
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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).
Root cause tag: labeling and UDI
FDA root cause: 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 -20C, 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.
Product codes and lots: All lots. Last lot of Kit distributed with the old IFU is 20210914.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0452-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0452-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-12	2022-01-04

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)