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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84274

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 02, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Polymer Technology Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

Z-0832-2020
Recall number
Z-0832-2020
Initiated
December 02, 2019
Classification
Class II
Status
Terminated
Quantity
44,448 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932700016

Distribution pattern

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.

device · product 2 of 4

PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702

Z-0833-2020
Recall number
Z-0833-2020
Initiated
December 02, 2019
Classification
Class II
Status
Terminated
Quantity
44,448 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00381932702010

Distribution pattern

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.

device · product 3 of 4

Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

Z-0834-2020
Recall number
Z-0834-2020
Initiated
December 02, 2019
Classification
Class II
Status
Terminated
Quantity
44,448

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040040539

Distribution pattern

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.

device · product 4 of 4

Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

Z-0835-2020
Recall number
Z-0835-2020
Initiated
December 02, 2019
Classification
Class II
Status
Terminated
Quantity
44,448 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Serial Numbers shipped during the 11/1/2016 to 10/25/2019 timeframe. UDI: 00304040037713

Distribution pattern

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.