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PTS Panels Lipid Panel test strip: IVD Lipid Panel Test… recallZ-2157-2019 · Polymer Technology Systems, Inc. · initiated Jun 7, 2019

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

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

FDA root cause category: Under Investigation by firm

What the company is doing

PTS Diagnostic issued Medical Device Recall issued letter on June 7, 2019 via certified mail, letter provides reason for recall, health risk and action to take: Immediately check your inventories and, if you have further distributed this product, please identify the users and notify them at once of this product recall. 1. Immediately check your inventories and segregate any remaining materials from lot P901.2. Distributors should immediately forward this notice and response form to all customers/users who may have received this product. 3. Acknowledge receipt of this instruction by completing the attached form, even if you do not have affected product on hand.4. If you have remaining stock of lot P901, hold that stock in quarantine. Our Customer Care team will contact you to arrange for return of the materials.

Recall details

Recall number
Z-2157-2019
Status
Terminated
Initiated by the company
Jun 7, 2019
Recalling firm
Polymer Technology Systems, Inc.
Quantity
1,887 vials US; 2,728 vials OUS
Product code
CHH
FDA submissions
K151545
Distribution
Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan

Product description

PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

Code information (models, lots, serial numbers)

Lot Number: P901 Exp. Date: 8/17/2020 (01) 00381931710016 (17) 200817 (10) P901

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 83097).

Sources and updates

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