Food, drugs, devices › Ortho-Clinical Diagnostics
Device recall: VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
FDA enforcement event 68271 is a device recall by Ortho-Clinical Diagnostics of Rochester, NY, initiated 10 Apr 2014 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 May 2018. 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
"Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected"
Distribution
"Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1734-2014 | VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. | Domestic - 82, Foreign - 213 units | Class II | Terminated | 18 Jun 2014 |
| Z-1735-2014 | VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. | Domestic - 835 units, Foreign - 921 units | Class II | Terminated | 18 Jun 2014 |
| Z-1736-2014 | VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use. | Domestic - 597 units, Foreign - 1381 units | Class II | Terminated | 18 Jun 2014 |
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: "Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution including US Nationwide, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 May 2018. "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.