FDAClass IIMay 29, 2019

CHOL+HDL+GLU test strips recall

CHOL+HDL+GLU test strips, REF 2412

Why was CHOL+HDL+GLU test strips recalled?

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 displayed

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

I808 I809 I811 I812 I814

Product
CHOL+HDL+GLU test strips, REF 2412
Recalling firm
Polymer Technology Systems, Inc.
Quantity
67643 total
Distribution
Domestic distribution nationwide.
Recall date
May 29, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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