Z-1729-2015Class II

Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical...

Name: Z-1729-2015 Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical...
Creator: Ortho-Clinical Diagnostics
Published: 2015-04-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-04-06 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for... on 2015-04-06. FDA classified it as Class II and gives the reason as "Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1729-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-06
Posted: 2015-06-08
Terminated: 2018-05-25
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Clinical Diagnostics distributed correction notification letters dated April 6, 2015, and response forms to their customers via courier service. All urine patient results that require pretreatment was advised to refer to the notice of correction for instructions. Correction notices should also be posted beside the device user documentation for easy reference. Customers were advised to complete and return the Confirmation of Receipt before April 20, 2015. Customers with questions may contact the Customer Technical Service at 1- 800-421-3311 anytime.
Quantity in commerce: 2,387 units Total (987 domestically & 1400 internationally)
Distribution: Worldwide Distribution - US Nationwide, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
Product codes and lots: Product Code: 6801876 Unique Device Identifier Numbers: 10758750001576

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1729-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1728-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08
Z-1729-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code JJE

K063144Class IVitros 5,1 Fs Chemistry System with Engen Laboratory Automation SystemOrtho-Clinical Diagnostics, Inc. / cleared 2006-11-13

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)