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U.S. Department of Health and Human Services

Class 3 Device Recall Henry Schein Lipid Panel Test Strips

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  Class 3 Device Recall Henry Schein Lipid Panel Test Strips see related information
Date Initiated by Firm June 07, 2019
Create Date August 05, 2019
Recall Status1 Terminated 3 on July 08, 2020
Recall Number Z-2158-2019
Recall Event ID 83097
510(K)Number K151545  
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
Product 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 (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 Lot Number: P901 Exp. Date: 8/17/2020 (01) 10304040037741 (17) 200817 (10) P901
Recalling Firm/
Manufacturer		 Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis IN 46268-2175
For Additional Information Contact SAME
317-870-5610
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 559 vials
Distribution Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHH and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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