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PTS Panels CHOL+GLU Test Strips (REF 1765) recallZ-1543-2018 · Polymer Technology Systems, Inc. · initiated Mar 14, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Polymer Technology Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

FDA root cause category: Under Investigation by firm

What the company is doing

Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.

Recall details

Recall number
Z-1543-2018
Status
Terminated
Initiated by the company
Mar 14, 2018
Recalling firm
Polymer Technology Systems, Inc.
Product code
NBW
FDA submissions
K041750
Distribution
OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

Product description

PTS Panels CHOL+GLU Test Strips (REF 1765)

Code information (models, lots, serial numbers)

Lot # A705  UDI (01)00381931765016(17)180813(10)A705

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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