Recall Z-1740-2022
Microbiologics Inc · initiated July 27, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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
Codes / lots: 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.
Reason for recall
Product not registered for use in the UK
FDA-determined 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.
Details
- Recall number
- Z-1740-2022
- Initiated
- July 27, 2022
- Posted by FDA
- September 14, 2022
- Terminated
- August 2, 2024
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 2
- Distribution
- International distribution to the country of United Kingdom.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN