Recall Z-0699-2022— Microbiologics Inc
Class II · Terminated
Class II FDA medical device recall by Microbiologics Inc, initiated 2017-06-06, terminated 2023-01-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.. Reason: Real-time shelf life testing failed at 24 months.
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-06
- Terminated
- 2023-01-17
- Firm location
- Saint Cloud, MN, United States
Product description
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2¿C-25¿C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.
Reason for recall
Real-time shelf life testing failed at 24 months
Data sourced from openFDA. This site is unofficial and independent of the FDA.