Z-0417-2015Class II

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

Name: Z-0417-2015 MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro...
Creator: Diagnostic Hybrids Inc
Published: 2014-10-16
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-10-16 / Terminated / root cause: design

FDA source

Diagnostic Hybrids Inc began a recall of MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic on 2014-10-16. FDA classified it as Class II and gives the reason as "Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0417-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-16
Posted: 2015-09-03
Terminated: 2015-09-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Product code: JZH Factor B, Antigen, Antiserum, Control
Reason for recall: Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Root cause tag: design
FDA root 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 [email protected] 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.
Product codes and lots: Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0417-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0417-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-03

Product code JZH

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)