Polymer Technology Systems Recalls CHOL+HDL+GLU Test Strips
Polymer Technology Systems is recalling CHOL+HDL+GLU test strips because they may not fit tightly into the optical block, potentially causing incorrect results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. The hazard 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 CHOL+HDL+GLU test strips, REF 2412. The recall involves 67,643 units distributed domestically nationwide. The affected lots are identified by codes I808, I809, I811, I812, and I814.
The recall was initiated because some lots of 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 who have these test strips should stop using them and contact Polymer Technology Systems, Inc. for further instructions or a refund.
The recalled product
- Product
- CHOL+HDL+GLU test strips, REF 2412
- 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)
- I808 I809 I811 I812 I814
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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