MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic

FDA device recall Z-0417-2015 · posted 2015-09-03 · Terminated

Recall details

Recalling firm

Diagnostic Hybrids Inc

Reason for recall

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

JZH

Quantity affected

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.

Date initiated

2014-10-16

Date posted

2015-09-03

Date terminated

2015-09-03

Location

Athens, OH