Device recall: VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) -…
Class III FDA enforcement event 80712. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not affected. The current Cl- LoQ is 5 mmol/L and the LoQ determined by this investigation is 15 mmol/L.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Ortho-Clinical Diagnostics started this device recall on 11 Jul 2018. The firm address in the FDA record is in Rochester, NY. FDA put the recall in Class III. FDA event 80712 has 1 product record. The first FDA enforcement report date is 26 Sep 2018. The record gives the status Terminated, with the termination date 11 Aug 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US Nationwide- The products were distributed to the following foreign countries: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France,…
Recalling firm
Ortho-Clinical Diagnostics, Rochester, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3184-2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry… | 168919 | Class III | Terminated | 26 Sep 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class III
- 4%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 105
Other events of the firm
Official channels
- FDA enforcement report Z-3184-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 80712. https://recallregister.com/fda/iii/80712/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US Nationwide- The products were distributed to the following foreign countries: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France,…
- What quantity of product is in FDA event 80712?
- The FDA record gives this quantity:
168919
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 4% of the 1,074 device events that started in 2018 are in Class III.