PTS Panels® Lipid Panel Test Strips 1710Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K151545); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 7, 2019Class IIITerminated

   The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901

   Z-2157-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151545. One submission often covers many models, so check the product and lot details in each record.

• Z-2158-2019 · Jun 7, 2019 · Terminated
  Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL