Z-0058-2019Class II

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

Name: Z-0058-2019 VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Creator: Ortho Clinical Diagnostics Inc
Published: 2018-07-12
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-07-12 / Open, Classified / root cause: design

FDA source

Ortho Clinical Diagnostics Inc began a recall of VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 on 2018-07-12. FDA classified it as Class II and gives the reason as "The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0058-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-07-12
Posted: 2018-10-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Product code: CGN Acid, Folic, Radioimmunoassay
Reason for recall: The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
Root cause tag: design
FDA root cause: Device Design
Action: On 12 July 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products (i.e., VITROS 3600, 5600 and/or ECi/ECiQ Systems) to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 7880
Distribution: Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.
Product codes and lots: 2470 2480 2490 2501 2510 2521

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0058-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0058-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0059-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0060-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-03
Z-0061-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-03

Product code CGN

K001266Class IIVitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitamin B12/folate Reagent Pack 3, Products Red Cell Folate PaOrtho-Clinical Diagnostics, Inc. / cleared 2000-05-02

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)