Food, drugs, devices › Ortho-Clinical Diagnostics
Device recall: VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family me
Ortho-Clinical Diagnostics (Rochester, NY) initiated this device recall on 29 Sep 2014; FDA lists 1 product record under event 69727, classified Class III.
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. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 3 Apr 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
"Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2."
Distribution
"Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1004-2015 | VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of… | 12 units | Class III | Terminated | 28 Jan 2015 |
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: "Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2."
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 - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Apr 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.