Device recall: Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer…
Class II FDA enforcement event 76854. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.
Class II, in the words of FDA
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
Roche Diagnostics Corporation started this device recall on 21 Mar 2017. The firm address in the FDA record is in Indianapolis, IN. FDA put the recall in Class II. FDA event 76854 has 1 product record. The first FDA enforcement report date is 17 May 2017. The record gives the status Terminated, with the termination date 2 Oct 2017.
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.
US Nationwide.Distribution
Recalling firm
Roche Diagnostics Corporation, Indianapolis, IN.
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-2049-2017 | Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for… | 3946 | Class II | Terminated | 17 May 2017 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 26
Other events of the firm
Official channels
- FDA enforcement report Z-2049-2017The 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 76854. https://recallregister.com/fda/ii/76854/. 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:
US Nationwide.Distribution
- What quantity of product is in FDA event 76854?
- The FDA record gives this quantity:
3946
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.