Biomeme, Inc.

FDA recalling firm · 3 enforcement events · 3 product records · 2020–2021 · PA

Biomeme, Inc. has 3 FDA enforcement events on this register (3 product records) between 2020 and 2021: 3 device; the busiest year was 2021 with 2.

0% of its events are Class I; the most common class is Class II (2). 0 events are listed as ongoing; the recalling firm's address is in PA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
20 Oct 2021	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	Device	Class II	1	Terminated
5 Jan 2021	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…	Device	Class III	1	Terminated
23 Oct 2020	The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2…	Device	Class II	1	Terminated

By type and class

Device3

Class II2

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Biomeme, Inc. by year initiated.

Questions and answers

How many FDA recalls has Biomeme, Inc. had?

3 enforcement events (3 product records) on this register, 2020–2021: 3 device.

Are any Biomeme, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Biomeme, Inc. recalls?

2 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.