CLASS II Device recall · Reported 1 Jan 2020 · FDA Enforcement Report
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number recalled
Polymer Technology Systems is recalling PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or, distributed in 16 states. The recall was initiated on 15 Mar 2016 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-0741-2020
- FDA event ID
- 84264
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2016
- FDA classified
- 26 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 15 Mar 2016 | Recall initiated by company | |
| 26 Dec 2019 | Classified by FDA | +1381 days |
| 1 Jan 2020 | 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
This lot of test strips is showing an under-recovery when tested against a reference method.
Product as listed by the FDA
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Where it was distributed
The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
CaliforniaConnecticutFloridaIndianaMassachusettsMarylandMichiganMinnesotaNorth CarolinaNew JerseyNew MexicoNew YorkOregonPennsylvaniaTennesseeWisconsin
Questions about this recall
Is PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or recalled?
Yes. Polymer Technology Systems recalled PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or on 15 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-0741-2020.
Why was it recalled?
This lot of test strips is showing an under-recovery when tested against a reference method.
Which lots are affected?
Lot Number I502, UDI 00381932412018
Where was it sold?
The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
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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