Z-1765-2017Class II

VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical...

Name: Z-1765-2017 VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical...
Creator: Ortho-Clinical Diagnostics
Published: 2017-03-07
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-03-07 / Terminated / root cause: manufacturing process

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK on 2017-03-07. FDA classified it as Class II and gives the reason as "Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing...". 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-1765-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Posted: 2017-04-08
Terminated: 2019-06-14
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Product code: NBC Test, Natriuretic Peptide
Reason for recall: Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 3/7/2017, IMPORTANT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-048) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers and distributors who were shipped VITROS NT-proBNP Reagent Packs, Lots 1570, 1580 and/or 1590 to inform them of the issue and provided further instructions.
Quantity in commerce: US: 6324; Foreign: 1868
Distribution: Worldwide: United States, Puerto Rico, Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
Product codes and lots: Lot 1570 (expiry 22 March 2017), Lot 1580 (expiry 13 April 2017), Lot 1590 (expiry 27 April 2017)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1765-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1765-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-08

Product code NBC

K060632Class IIVitros Immunodiagnostic Products Nt Pro-Bnp Reagent Pack,calibrators,range Verifiers,680 2156,680 2157,680 2158Ortho-Clinical Diagnostics, Inc. / cleared 2006-06-06

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)