Z-1132-2021Class II

LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome...

Name: Z-1132-2021 LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome...
Creator: LumiraDx
Published: 2021-01-11
License: https://open.fda.gov/license/

LumiraDx / initiated 2021-01-11 / Terminated / root cause: manufacturing process

FDA source

LumiraDx began a recall of LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog... on 2021-01-11. FDA classified it as Class II and gives the reason as "Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1132-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-11
Posted: 2021-02-17
Terminated: 2021-12-03
Recalling firm: LumiraDx
Product: LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 01/28/2021, Lumiradx issued Urgent Medical Device Recall notices to customers via letter notifying customers the potential of false positive results in specified lots of LumiraDx SARS-CoV-2 Antigen (Ag) Test Strip. A false positive test result of a patient could result in potential exposure to unnecessary treatment or quarantine. (Updated 3/15/2021) On 2/26/2021, Lumiradx issued a second Urgent Medical Device Recall notice to customers via letter expanding the recall to include 3 additional lots. These lots are subject to recent feedback from a small number of customers regarding a small to moderate elevation in numbers of reported false positive patient test results.
Quantity in commerce: 3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
Distribution: Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.
Product codes and lots: Catalog #:L016000109048 Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-17

Product code QKP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)