Z-0714-2012

VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester...

Name: Z-0714-2012 VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester...
Creator: Ortho-Clinical Diagnostics
Published: 2011-11-10
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2011-11-10 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High... on 2011-11-10. The reason FDA records is "Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability". 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-0714-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2012-01-11
Terminated: 2018-07-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 16, REF 680 1700, 5x1 mL --- Ortho-Clinical Diagnostics, Rochester, NY USA -- Ortho-Clinical Diagnostics High Wycomber, UK. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of rheumatoid factor (RF).
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A letter was sent to customers via overnight delivery on 11/10/2011. The letter informed customers they should discontinue using and discard all remaining VITROS Calibrator Kit 16, Lot 1630; Complete and return the attached Confirmation of Receipt form upon receipt of the notification. Once the fax reply is received, the firm will begin the replacement order process; forward the notification to all departments and areas that use the VITROS Calibrator Kit 16, Lot 1630; and post the notification by each VITROS Chemistry or Integrated System in your facility that uses the VITROS Calibrator Kit 16, Lot 1630 or with VITROS user documentation.
Quantity in commerce: 768 kits
Distribution: Class II Recall: Worldwide Distribution - USA (Nationwide) and the countries of Brazil, Canada, Chile, China, Colombia, England, France, Mexico, Panama, Singapore, Spain, Venezuela.
Product codes and lots: Lot 1630

Product code DHR

K041863Class IIVitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FsOrtho-Clinical Diagnostics, Inc. / cleared 2004-09-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)