CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report
CHOL+HDL+GLU test strips recalled by Polymer Technology Systems
Polymer Technology Systems is recalling CHOL+HDL+GLU test strips, distributed nationwide in the US. The recall was initiated on 16 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1373-2019
- FDA event ID
- 82331
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2019
- FDA classified
- 23 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 16 Jan 2019 | Recall initiated by company | |
| 23 May 2019 | Classified by FDA | +127 days |
| 29 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
CHOL+HDL+GLU test strips, REF 2412
Where it was distributed
Domestic distribution nationwide.
Questions about this recall
Is CHOL+HDL+GLU test strips recalled?
Yes. Polymer Technology Systems recalled CHOL+HDL+GLU test strips on 16 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-1373-2019.
Why was it 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
Which lots are affected?
I808 I809 I811 I812 I814
Where was it sold?
Domestic distribution nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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