Helix Elite" Molecular Standards: Inactivated Standard. recall
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
Why was Helix Elite" Molecular Standards: Inactivated Standard. recalled?
Real-time shelf life testing failed at 24 months
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: HE0041N; Lot Number: HE0041N-102-1; UDI: 10845357042153
- Product
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- Recalling firm
- Microbiologics Inc
- Quantity
- 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.
- Recall date
- March 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)