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Recall Observatory FDA recall evidence

Device product

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

Z-1372-2019

January 16, 2019

Class II

Product summary

Firm
Polymer Technology Systems, Inc.
Event
Event 82331
Status
Terminated
Classification
Class II
Quantity
67643 total
Official record key
device-enforcement:Z-1372-2019

Official wording

Reason: 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

Code information: Q802 Q811 Q813 Q816 Q820 Q823 Q831 Q903

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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