The Recall Desk
ModerateFDA (Devices)·Z-1372-2019·Announced 2019-05-29

Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential incorrect diagnostic results due to a mechanical fit issue, without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Polymer Technology Systems, Inc. is recalling specific lots of Lipid Panel test strips, which are used as components of smart bundles. The affected product is identified by REF 2729 and is also private labeled under Henry Schein as REF 570-0412. A total of 67,643 units were distributed domestically nationwide.

The recall was initiated because some lots of the test strips do not fit tightly into the optical block. This defect may cause the strips to fall out during analysis, which could lead to an incorrect diagnostic result. The specific lots affected are identified by the codes Q802, Q811, Q813, Q816, Q820, Q823, Q831, and Q903.

Healthcare providers and consumers should check their inventory for these specific reference numbers and lot codes. If the product matches the recalled description, it should be removed from use and returned to the distributor or manufacturer for credit or replacement, per standard recall procedures.

The recalled product

Product
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Manufacturer
Polymer Technology Systems, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
67,643

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Q802 Q811 Q813 Q816 Q820 Q823 Q831 Q903

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Polymer Technology Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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