Nucleic acid-based in vitro diagnostic devices for the detection of… — Class III medical device recall Z-0940-2021
Terminated recall by Biomeme, Inc., reported 2021-02-10, distributed in CA, FL, IN, KY, MD, NY, OH, PA…. Users cannot complete testing due to a sign-error in the software component that controls the filter movement
| Recall number | Z-0940-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomeme, Inc., Philadelphia, PA, United States |
| Recall initiated | 2021-01-05 |
| Classified | 2021-01-31 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2021-06-11 |
| Distributed | CA, FL, IN, KY, MD, NY, OH, PA, TX |
| Countries outside the US | CA |
| Quantity | 147 systems |
| Reason classes | potency, software |
| Model numbers | 1000003, 1000018 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0940-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.