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
This recall has been terminated (originally issued September 14, 2022).
- Company
- Microbiologics Inc
- Recall Initiated
- July 27, 2022
- Posted
- September 14, 2022
- Terminated
- August 2, 2024
- Recall Number
- Z-1740-2022
- Quantity
- 2
- Firm Location
- Saint Cloud, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Product not registered for use in the UK
Distribution
International distribution to the country of United Kingdom.
Lot / Code Info
a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.
Root Cause
Process control
Action Taken
Microbiologics initially contacted the consignee via email on 07/27/2022. A formal letter was provided via email on 08/15/2022. The notification instructed the consignee to review lab procedures to understand how the recall affects their usage, discard any units depending on the lab procedures, complete and return the response form, maintain the recall letter for record, and contact Microbiologics for replacement if needed.