Z-0971-2012

VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit...

Name: Z-0971-2012 VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit...
Creator: Ortho-Clinical Diagnostics
Published: 2011-10-27
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2011-10-27 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS... on 2011-10-27. The reason FDA records is "Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products...". 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-0971-2012
Status: Terminated
Initiated: 2011-10-27
Posted: 2012-02-07
Terminated: 2016-02-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 is used 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 albumin in urine. Ortho-Clinical Diagnostics Inc.
Product code: JIT Calibrator, Secondary
Reason for recall: Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: All consignees were sent "Important Product Correction Notification" communications (dated 10/27/11) beginning on 10/27/11 informing them of the issue, and instructing them to discontinue use of their remaining inventory of VITROS Chemistry Products Calibrator Kit 24, VITROS Chemistry Products mALB reagent, and VITROS Chemistry Products mALB Performance Verifiers. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.
Quantity in commerce: 4436 units worldwide (domestic - 2201; foreign - 2235)
Distribution: Worldwide Distribution - USA, including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product codes and lots: Kit Lot 2430 (exp. 11/16/11), Kit Lot 2440 (exp. 01/08/12), Kit Lot 2450 (03/09/12), Kit Lot 2471 (exp. 7/14/12)

Product code JIT

K042643Class IIVitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I and IIOrtho-Clinical Diagnostics, Inc. / cleared 2004-11-18

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)