Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Targ
Summary
The FDA issued a Class II for Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory by Microbiologics Inc. Reason: Real-time shelf life testing failed at 24 months.
Details
Source
Device Recall
External ID
Z-0699-2022
Action Date
2022-03-09
Status
Terminated
Category
device
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.
Lot/Code Info: Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023
Quantity Affected: 1 unit
Reason for Recall
Real-time shelf life testing failed at 24 months
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2017-06-06
Company
Saint Cloud, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0699-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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