INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Summary
The FDA issued a Class II for INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 by PHASE SCIENTIFIC INTERNATIONAL LIMITED. Reason: COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 Februar.
Details
Source
Device Recall
External ID
Z-0738-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
Lot/Code Info: Lot: 22S0388-R01, Exp: 05-Apr-2024
Quantity Affected: 360 Kits
Reason for Recall
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.
Distribution
US Nationwide distribution including in the states of CA, NY, VT, WA, OH, MD , NJ, PA, MS, NC, AL, MI, MA, DE, GA, TX, OR, MO , WI , ME, IL, VA, CO, NM, NH, LA, KY, DC, MN, MO, FL, AR, MD, TN, UT, WY, SC, WI, CT, KS, SD.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-25
Company
Sha Tin, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHASE SCIENTIFIC INTERNATIONAL LIMITED) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHASE SCIENTIFIC INTERNATIONAL LIMITED have FDA actions?
This is the only FDA action we have on record for PHASE SCIENTIFIC INTERNATIONAL LIMITED in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0738-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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