CLASS II Device recall · Reported 29 Jan 2020 · FDA Enforcement Report
PTS Diagnostics CardioChek Plus Professional Analyzer recalled
Polymer Technology Systems is recalling PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box, distributed nationwide in the US. The recall was initiated on 2 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0833-2020
- FDA event ID
- 84274
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Dec 2019
- FDA classified
- 21 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Dec 2019 | Recall initiated by company | |
| 21 Jan 2020 | Classified by FDA | +50 days |
| 29 Jan 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
Where it was distributed
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, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.
Questions about this recall
Is PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box recalled?
Yes. Polymer Technology Systems recalled PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box on 2 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-0833-2020.
Why was it recalled?
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.
Which lots are affected?
All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932702010
Where was it sold?
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, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Polymer Technology Systems
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | A1CNow+ Multi-Test HbA1c System consists recalled | Polymer Technology Systems | Labeling Errors | Nationwide |
| Device | CLASS III | PTS Panels CHOL+GLU Test Strips recalled by Polymer Technology Systems | Polymer Technology Systems | Packaging Defects | Nationwide |
| Device | CLASS II | PTS Detect Cotinine recalled by Polymer Technology Systems | Polymer Technology Systems | Other | Nationwide |
| Device | CLASS II | Henry Schein CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Henry Schein CardioChek Starter Kit recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |