Device recall: PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Class II FDA enforcement event 84274. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
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
Polymer Technology Systems, Inc. started this device recall on 2 Dec 2019. The firm address in the FDA record is in Indianapolis, IN. FDA put the recall in Class II. FDA event 84274 has 4 product records. The first FDA enforcement report date is 29 Jan 2020. The record gives the status Terminated, with the termination date 6 Jul 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.
The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands,…
Recalling firm
Polymer Technology Systems, Inc., Indianapolis, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0832-2020 | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 | 44,448 total | Class II | Terminated | 29 Jan 2020 |
| Z-0833-2020 | PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702 | 44,448 total | Class II | Terminated | 29 Jan 2020 |
| Z-0834-2020 | Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 | 44,448 | Class II | Terminated | 29 Jan 2020 |
| Z-0835-2020 | Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411 | 44,448 total | Class II | Terminated | 29 Jan 2020 |
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 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 8
Other events of the firm
Official channels
- FDA enforcement report Z-0832-2020The 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 84274. https://recallregister.com/fda/ii/84274/. 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:
The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands,…
- What quantity of product is in FDA event 84274?
- The event has 4 product records. The first record gives this quantity:
44,448 total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.