Z-0699-2022Class II

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain...

Name: Z-0699-2022 Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain...
Creator: Microbiologics Inc
Published: 2017-06-06
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2017-06-06 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR... on 2017-06-06. FDA classified it as Class II and gives the reason as "Real-time shelf life testing failed at 24 months". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0699-2022
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Posted: 2022-03-01
Terminated: 2023-01-17
Recalling firm: Microbiologics, Inc.
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 2C-25C 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.
Product code: OHQ Multi-Analyte Controls Unassayed
Reason for recall: Real-time shelf life testing failed at 24 months
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Microbiologics notified customers on about 06/06/2017 via email containing a letter. The letters indicated the affected products and instructed customers to update their records with the corrected expiration date, which was provided for each affected lot.
Quantity in commerce: 1 unit
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.
Product codes and lots: Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0699-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0698-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0699-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0700-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01
Z-0701-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-01

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)