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Recall Observatory FDA recall evidence

Device product

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

Z-0741-2020

March 15, 2016

Class II

Product summary

Firm
Polymer Technology Systems, Inc.
Event
Event 84264
Status
Terminated
Classification
Class II
Quantity
6467
Official record key
device-enforcement:Z-0741-2020

Official wording

Reason: This lot of test strips is showing an under-recovery when tested against a reference method.

Code information: Lot Number I502, UDI 00381932412018

Distribution pattern: The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This lot of test strips is showing an under-recovery when tested against a reference method.