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

Recall Z-0135-2023 — LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls pr

U.S. FDA — Device Enforcement · United States · 2022-09-23 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0135-2023
Date of alert: 2022-09-23
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: LumiraDx
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 2002204017

Reported risk: Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC

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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