Polymer Technology Systems Recalls Lipid Panel Test Strips Due to Fit Issues
Polymer Technology Systems is recalling Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (incorrect medical results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Polymer Technology Systems, Inc. is recalling Lipid Panel test strips, REF 1710, which are also private labeled under Henry Schein as REF 570-0414. The recall involves 67,643 units that 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 result being displayed.
Consumers and healthcare providers should stop using the affected test strips and contact Polymer Technology Systems for further instructions.
The recalled product
- Product
- Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
- Manufacturer
- Polymer Technology Systems, Inc.
- 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)
- P832
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.
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