Z-1337-2013Class III

VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High...

Name: Z-1337-2013 VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High...
Creator: Ortho-Clinical Diagnostics
Published: 2013-04-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-04-03 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the... on 2013-04-03. FDA classified it as Class III and gives the reason as "Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality...". 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-1337-2013
Classification: Class III
Status: Terminated
Initiated: 2013-04-03
Posted: 2013-05-17
Terminated: 2017-03-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho Clinical Diagnostic sent a " Important Product Correction Notification" letter dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed of the issue and advised they must discontinue storage of opened-reconstituted vials of VITROS CK-MB Calibrators frozen at -20 degrees Celsius (-4 degrees Farenheit). The same day, the Distributor letters were sent via US Postal Service Priority Mail or FedEx overnight courier to US Distributor consignees who were informed of the issue and instructed to notify their customers of the issue and actions. Also on April 3, 2013, the foreign affiliates were informed of the issue by e-mail and instructed to notify their consignees of the issue and actions. Confirmation of Receipt - Important Response Required so that we can complete our records, please return this form to us no later than April 19, 2013. FAX: 1-888-557-3759 or 1-585-453-4110 We apologize for any inconvenience this may have caused your laboratory. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.
Quantity in commerce: Domestic: 3019 units, Foreign: 905 units
Distribution: Worldwide Distribution - Nationwide 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: Lots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1337-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1337-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-17

Product code JIX

K973030Class IVitros Immunodiagnostics Products/ck-Mb Reagent Pack(gem.1300)/ck-Mb Calibrators (Gem.c300)Johnson & Johnson Clinical Diagnostics, Inc. / cleared 1997-09-04

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)