Food, drugs, devices › Ortho-Clinical Diagnostics
Device recall: VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) -
Ortho-Clinical Diagnostics (Rochester, NY) initiated this device recall on 11 Jul 2018; FDA lists 1 product record under event 80715, 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 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 19 Aug 2020. 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
"The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring…"
Distribution
"Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3193-2018 | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600… | 627543 | Class III | Terminated | 26 Sep 2018 |
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: "The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring…"
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. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Aug 2020. "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.