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.
FDA Recall Z-2157-2019 · Posted None
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Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeCHH
Date Initiated2019-06-07
Date Terminated2020-07-08
Product Quantity1,887 vials US; 2,728 vials OUS
Reason for Recall
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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