Polymer Technology Systems, Inc.: Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.; Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF

Agency Publication Date: May 23, 2019

Affected Products

Product: Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

P832

Product: Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

Q802 Q811 Q813 Q816 Q820 Q823 Q831 Q903

Product: CHOL+HDL+GLU test strips, REF 2412

I808 I809 I811 I812 I814

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82331

Status: Resolved

Manufacturer: Polymer Technology Systems, Inc.

Manufactured In: United States

Units Affected: 3 products (67643 total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.