Food, drugs, devices › Ortho-Clinical Diagnostics
Device recall: VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP,
FDA enforcement event 64901 is a device recall by Ortho-Clinical Diagnostics of Rochester, NY, initiated 3 Apr 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 2 Mar 2017. Initiation: voluntary: firm initiated. Ortho-Clinical Diagnostics has 105 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ortho-Clinical Diagnostics, Rochester, NY.
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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1337-2013 | 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… | Domestic: 3019 units, Foreign: 905 units | Class III | Terminated | 29 May 2013 |
Context
Other enforcement events for Ortho-Clinical Diagnostics
All 105 events for Ortho-Clinical Diagnostics
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 control results."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.