Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated
FDA device recall Z-1740-2022 · posted 2022-09-14 · Terminated
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- Product not registered for use in the UK
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OHQ
- Quantity affected
- 2
- Distribution
- International distribution to the country of United Kingdom.
- Date initiated
- 2022-07-27
- Date posted
- 2022-09-14
- Date terminated
- 2024-08-02
- Location
- Saint Cloud, MN
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