Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0940-2021 — 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 Softwar

U.S. FDA — Device Enforcement · United States · 2021-01-05 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0940-2021
Date of alert: 2021-01-05
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Biomeme, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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