Z-1707-2015Class III

VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No...

Name: Z-1707-2015 VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No...
Creator: Ortho-Clinical Diagnostics
Published: 2015-05-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-05-06 / Terminated / root cause: labeling and UDI

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal... on 2015-05-06. FDA classified it as Class III and gives the reason as "The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1707-2015
Classification: Class III
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-06-04
Terminated: 2017-09-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
Reason for recall: The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 5/06/2015, Customer Letter and Verification Form (Ref. CL15-095) were sent notifying the users of the issue and advised them of the required actions. The notification was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. On 5/06/2015, Distributor Letter (Ref. DL15-095) was sent via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and actions. For questions,questions, please contact Customer Technical Services at 1-800-421-3311 at any time.
Quantity in commerce: Domestic: 898 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot 3082, expiry date 7/27/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1707-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1707-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code CDP

K964310Class IIVitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total Caliibration (Gem.c010)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1996-11-27

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)