Device recall: RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Class II FDA enforcement event 79968. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
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
Randox Laboratories started this device recall on 4 May 2018. The firm address in the FDA record is in Kearneysville, WV. FDA put the recall in Class II. FDA event 79968 has 1 product record. The first FDA enforcement report date is 13 Jun 2018. The record gives the status Terminated, with the termination date 16 Jun 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.
US Distribution including Puerto Rico and the state of : West Virginia.
Recalling firm
Randox Laboratories, Kearneysville, WV.
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-2059-2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. | 41 analyzers | Class II | Terminated | 13 Jun 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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Feb 2023 | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cata | Device | Class II | 1 |
| 11 Aug 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | Device | Class III | 2 |
| 27 Apr 2017 | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clini | Device | Class III | 1 |
| 16 Sep 2016 | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2059-2018The 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 79968. https://recallregister.com/fda/ii/79968/. 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 Distribution including Puerto Rico and the state of : West Virginia.
- What quantity of product is in FDA event 79968?
- The FDA record gives this quantity:
41 analyzers
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.