PTS Panels Lipid Panel test strip: IVD Lipid Panel Test recall: Labeling Error
PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total…
Why was PTS Panels Lipid Panel test strip: IVD Lipid Panel Test recalled?
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
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: P901 Exp. Date: 8/17/2020 (01) 00381931710016 (17) 200817 (10) P901
- Product
- PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total…
- Recalling firm
- Polymer Technology Systems, Inc.
- Quantity
- 1,887 vials US; 2,728 vials OUS
- Distribution
- Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
- Recall date
- August 14, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)