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Recall Observatory FDA recall evidence

Device product

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

Z-0833-2020

December 02, 2019

Class II

Product summary

Firm
Polymer Technology Systems, Inc.
Event
Event 84274
Status
Terminated
Classification
Class II
Quantity
44,448 total
Official record key
device-enforcement:Z-0833-2020

Official wording

Reason: 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.

Derived failure modes

  • 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.