Z-1499-2018Class III

MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex...

Name: Z-1499-2018 MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex...
Creator: Diagnostic Hybrids, Inc.
Published: 2015-11-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-11-03 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Hybrids, Inc. began a recall of MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum on 2015-11-03. FDA classified it as Class III and gives the reason as "A component of the kit was found to contain bacterial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1499-2018
Classification: Class III
Status: Terminated
Initiated: 2015-11-03
Posted: 2018-04-24
Terminated: 2020-08-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Product code: N/A
Reason for recall: A component of the kit was found to contain bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.
Quantity in commerce: 72 kits
Distribution: Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
Product codes and lots: Lot 052419

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1499-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24
Z-1498-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24
Z-1499-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24

Product code N/A

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)