Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Reported: March 9, 2022 Initiated: June 6, 2017 #Z-0700-2022
Product Description
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Reason for Recall
Real-time shelf life testing failed at 24 months
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 1
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.. Recalled by Microbiologics Inc. Units affected: 1.
Why was this product recalled? ▼
Real-time shelf life testing failed at 24 months
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0700-2022.
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