Class 2 Device Recall MicroVue Bb Plus EIA

• Date Initiated by Firm: October 16, 2014
• Date Posted: September 03, 2015
• Recall Status: Terminated on September 03, 2015
• Recall Number: Z-0417-2015
• Recall Event ID: 69545
• Product Classification: Factor b, antigen, antiserum, control - Product Code JZH
• Product: MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
• Code Information: Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)
• Recalling Firm/ Manufacturer: Diagnostic Hybrids Inc; 1055 E State St; Suite 100; Athens OH 45701-7911
• For Additional Information Contact: 740-589-3300
• Manufacturer Reason for Recall: Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
• FDA Determined Cause: Device Design
• Action: Quidel sent an Urgent Medical Device Recall letter dated October 16, 2014, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review their inventory and determine if they have of the affected product. If so, they should remove it from their inventory and destroy it immediately by discarding it into their normal biomedical waste stream. Complete the enclosed Certificate of Destruction. Upon receipt of the Certificate of Destruction, Quidel, will then schedule their shipment of replacement product. If consignees further distributed the affected product, they should identify the customers and provide them with the Urgent Medical Device Recall. Consignees were instructed to monitor and reconcile the quarantine of product with the customers as this information may need to be provided to the authorities. For questions regarding this recall call 740-589-3300. For technical support consignees should contact technicalsupport@quidel.com or call 800-874-1517.
• Quantity in Commerce: 171
• Distribution: Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.
• Total Product Life Cycle: TPLC 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.