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U.S. Department of Health and Human Services

Class 2 Device Recall Helix Elite

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 Class 2 Device Recall Helix Elitesee related information
Date Initiated by FirmJune 06, 2017
Create DateMarch 01, 2022
Recall Status1 Terminated 3 on January 17, 2023
Recall NumberZ-0697-2022
Recall Event ID 89446
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductMicrobiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209
Code Information Catalog Number: 8191, Lot Number: 8191-01, UDI: 70845357041240
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactBecky Neu
320-229-7073
Manufacturer Reason
for Recall		Real-time shelf life testing failed at 24 months
FDA Determined
Cause 2		Process design
ActionMicrobiologics 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 Commerce8 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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