Device recall: ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid…
Class II FDA enforcement event 81488. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
lack of 510K
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
Clark Laboratories, Inc. (dba,Trinity Biotech USA) started this device recall on 1 Nov 2018. The firm address in the FDA record is in Jamestown, NY. FDA put the recall in Class II. FDA event 81488 has 5 product records. The first FDA enforcement report date is 26 Dec 2018. The record gives the status Terminated, with the termination date 21 Jun 2022.
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.
IL, WV, NJ, AZ, MD, UT
Recalling firm
Clark Laboratories, Inc. (dba,Trinity Biotech USA), Jamestown, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0620-2019 | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | 14 devices | Class II | Terminated | 26 Dec 2018 |
| Z-0621-2019 | Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | 372 units | Class II | Terminated | 26 Dec 2018 |
| Z-0622-2019 | Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | 252 units | Class II | Terminated | 26 Dec 2018 |
| Z-0623-2019 | Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | 216 units | Class II | Terminated | 26 Dec 2018 |
| Z-0624-2019 | Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | 463 units | Class II | Terminated | 26 Dec 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
- 5Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Jul 2016 | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD | Device | Class III | 1 |
| 17 Nov 2014 | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD | Device | Class III | 1 |
| 27 Aug 2013 | Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies | Device | Class II | 1 |
| 29 May 2012 | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnost | Device | Class III | 1 |
Clark Laboratories, Inc. (dba,Trinity Biotech USA): all 5 events
Official channels
- FDA enforcement report Z-0620-2019The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 81488. https://recallregister.com/fda/ii/81488/. 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:
IL, WV, NJ, AZ, MD, UT
- What quantity of product is in FDA event 81488?
- The event has 5 product records. The first record gives this quantity:
14 devices
- 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.