Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Reported: September 21, 2022 Initiated: July 27, 2022 #Z-1740-2022
Product Description
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Reason for Recall
Product not registered for use in the UK
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 2
- Distribution
- International distribution to the country of United Kingdom.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N. Recalled by Microbiologics Inc. Units affected: 2.
Why was this product recalled? ▼
Product not registered for use in the UK
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2022. Severity: Low. Recall number: Z-1740-2022.
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