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FDAJanuary 16, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 570-0412

What to do

FDA enforcement status: Terminated

Brands named

polymer technology systemspolymerpolymer technology

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412 — Recall Details · AllClear