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Class 2 Device Recall Helix Elite |
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Date Initiated by Firm |
February 25, 2022 |
Create Date |
March 14, 2022 |
Recall Status1 |
Terminated 3 on January 16, 2024 |
Recall Number |
Z-0784-2022 |
Recall Event ID |
89694 |
Product Classification |
Multi-analyte controls unassayed - Product Code OHQ
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Product |
Mycoplasma genitalium Control Panel (Inactivated Pellet) |
Code Information |
Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053) |
Recalling Firm/ Manufacturer |
Microbiologics Inc 200 Cooper Ave N Saint Cloud MN 56303-4440
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For Additional Information Contact |
Becky Neu 320-229-7073
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Manufacturer Reason for Recall |
Distributed product did not undergo proper release testing.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to recall@microbiologics.com. |
Quantity in Commerce |
80 units |
Distribution |
Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA
OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam |
Total Product Life Cycle |
TPLC Device Report
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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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