Recall Z-0738-2024— PHASE SCIENTIFIC INTERNATIONAL LIMITED
Class II · Ongoing
Class II FDA medical device recall by PHASE SCIENTIFIC INTERNATIONAL LIMITED, initiated 2023-10-25. FDA's recall record names no specific 510(k) clearance for this event. Product: INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040. 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 February 2024. Expired tests could produce invalid or inaccurate results..
- Recalling firm
- PHASE SCIENTIFIC INTERNATIONAL LIMITED
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-25
- Firm location
- Sha Tin, N/A, Hong Kong SAR
Product description
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.