PTS Panels CHOL+HDL+GLU Test Strips recall
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Why was PTS Panels CHOL+HDL+GLU Test Strips recalled?
This lot of test strips is showing an under-recovery when tested against a reference method.
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?
Lot Number I502, UDI 00381932412018
- Product
- PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
- Recalling firm
- Polymer Technology Systems, Inc.
- Quantity
- 6467
- Distribution
- 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.
- Recall date
- January 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)