Device recall: VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro…
Class III FDA enforcement event 65247. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.
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 9 May 2013. The firm address in the FDA record is in Rochester, NY. FDA put the recall in Class III. FDA event 65247 has 2 product records. The first FDA enforcement report date is 3 Jul 2013. The record gives the status Terminated, with the termination date 12 Jun 2015.
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 Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,…
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
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1614-2013 | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and… | Domestic: 236,364; Foreign: 8,339 | Class III | Terminated | 3 Jul 2013 |
| Z-1615-2013 | VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems… | Domestic: 4,257; Foreign: 923 | Class III | Terminated | 3 Jul 2013 |
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 2013
- 1,236
- Share of these events in Class III
- 5%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 105
Other events of the firm
Official channels
- FDA enforcement report Z-1614-2013The 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 65247. https://recallregister.com/fda/iii/65247/. 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 Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico,…
- What quantity of product is in FDA event 65247?
- The event has 2 product records. The first record gives this quantity:
Domestic: 236,364; Foreign: 8,339
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 5% of the 1,236 device events that started in 2013 are in Class III.