LUCIRA™ HEALTH Provides Statement on Copan’s Recall of its FLOQSwabs
October 08 2021 - 6:00AM
Lucira Health, Inc. (“Lucira Health” or “Lucira”) (NASDAQ: LHDX), a
medical technology company focused on the development and
commercialization of transformative and innovative infectious
disease test kits, today commented on the recent recall of the
FLOQSwabs by supply partner Copan Italia SPA, or Copan.
Copan, who supplies FLOQSwabs included in the LUCIRA COVID-19
All-In-One Test Kit and LUCIRA CHECK IT COVID-19 Test Kit,
collectively the Test Kits, announced a recall of its FLOQSwabs.
According to Lucira’s records, Test Kits containing the recalled
Copan swabs were distributed from April 22, 2021 through September
22, 2021. Lucira estimates expenses related to the recalled Copan
swabs to be between $75,000 and $85,000 and intends to pass-through
all related expenses, including but not limited to third party and
legal costs, to Copan. In addition, Lucira notes the recalled Copan
swabs had no impact on revenue recorded during the distribution
period.
The recalled Copan swabs included in the Test Kits distributed
from April 22, 2021 through September 22, 2021 should not be used
and should be disposed. Lucira is offering a replacement swab for
customers who purchased a Test Kit containing a recalled Copan
swab. The lot numbers of the affected Test Kits are listed in the
table below.
Affected Lucira Kits |
|
Affected Lucira Kits |
REF: GLUC-2000 |
|
LOT: K07A111905214M1 |
LOT: K07A112704214M1 |
|
LOT: K07A111905214M2 |
LOT: K07A112704214M2 |
|
LOT: K07A112105214M1 |
LOT: K07A112704214M3 |
|
LOT: K07A112304214M1 |
LOT: K07A112804214M1 |
|
LOT: K07A112304214M2 |
LOT: K07A112804214M2 |
|
LOT: K07A112304214M3 |
REF: LUC-1000 |
|
LOT: K07A112404214M1 |
LOT: K07A111406214M1 |
|
LOT: K07A112404214M2 |
LOT: K07A111907214M1 |
|
LOT: K07A112404214M3 |
LOT: K07A112005214M1 |
|
LOT: K07A112604214M1 |
REF: LUC-2000 |
|
LOT: K07A112604214M2 |
LOT: K07A110106214M1 |
|
LOT: K07A112604214M3 |
LOT: K07A110505214M1 |
|
LOT: K07A112604214M4 |
LOT: K07A110505214M2 |
|
LOT: K07A112607214M1 |
LOT: K07A110605214M1 |
|
LOT: K07A112607214M2 |
LOT: K07A110605214M2 |
|
LOT: K07A112705214M1 |
LOT: K07A110608214M1 |
|
LOT: K07A112805214M1 |
LOT: K07A110705214M1 |
|
LOT: K07A113105214M1 |
LOT: K07A110906214M1 |
|
LOT: K07A113105214M2 |
LOT: K07A111006214M1 |
|
REF: LUC-3000 |
LOT: K07A111006214M2 |
|
LOT: K07A111409214M1 |
LOT: K07A111709214M3 |
|
LOT: K07A111907214M2 |
LOT: K07A111806214M1 |
|
|
About Lucira Health
Lucira is a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits. Lucira’s testing platform produces
lab quality molecular testing in a single-use, consumer-friendly,
palm-size test kit powered by two AA batteries. Lucira designed its
test kits to provide accurate, reliable, and on-the-spot molecular
test results anywhere and at any time. The LUCIRA™ CHECK IT
COVID-19 Test Kit (OTC) and LUCIRA™ COVID-19 All-In-One Test Kit
(Rx) are designed to provide a clinically relevant COVID-19 result
within 30 minutes from sample collection. For more information,
visit www.lucirahealth.com.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such forward-looking statements include statements
regarding, among other things, Lucira’s continued development and
commercialization of its transformative and innovative infectious
disease test kits and ability to increase sales. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Words such as “can” “plans,” “will,”
“may,” “anticipates,” “expects,” “potential” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon Lucira’s current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Actual results could differ materially
from those anticipated in such forward-looking statements as a
result of various risks and uncertainties, including our ability to
increase production, streamline operations and increase product
availability; the success of our test platform with COVID-19, the
impact to our business of the ongoing COVID-19 pandemic; any impact
on our ability to market our products; demand for our products due
to deferral of procedures using our products or disruption in our
supply chain; our ability to achieve or sustain profitability; our
ability to gain market acceptance for our products and to
accurately forecast and meet customer demand; our ability to
compete successfully; our ability to enhance our product offerings;
development and manufacturing problems; capacity constraints or
delays in production of our products; maintenance of coverage and
adequate reimbursement for procedures using our products; and
product defects or failures. These and other risks and
uncertainties are described more fully in the “Risk Factors”
section and elsewhere in our filings with the Securities and
Exchange Commission and available at www.sec.gov, including in our
most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q. Any forward-looking statements that we make in this
announcement speak only as of the date of this press release, and
Lucira assumes no obligation to update forward-looking statements
whether as a result of new information, future events or otherwise
after the date of this press release, except as required under
applicable law.
Media ContactKevin
Knightmedia@lucirahealth.com206-451-4823
Investor ContactGreg
ChodaczekInvestorrelations@lucirahealth.com347-620-7010
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