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U.S. Department of Health and Human Services

Class 2 Device Recall PTS Panels

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 Class 2 Device Recall PTS Panelssee related information
Date Initiated by FirmJanuary 16, 2019
Create DateMay 23, 2019
Recall Status1 Terminated 3 on June 24, 2020
Recall NumberZ-1372-2019
Recall Event ID 82331
510(K)NumberK023558 
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
ProductLipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Code Information Q802 Q811 Q813 Q816 Q820 Q823 Q831 Q903
Recalling Firm/
Manufacturer		 Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis IN 46268-2175
For Additional Information ContactKarmen Mercer
877-570-8610
Manufacturer Reason
for Recall		Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
FDA Determined
Cause 2		Device Design
ActionThe firm initially notified some of their customers from January through March 2019 with a Customer Bulletin. On March 28, 2019, the firm issued an updated Urgent Medical Device Recall letter to all affected customers. The letter alerted customers to the potential for test strips to slip out of the analyzer. Actions to be taken by the Customer/User: 1. Closely follow the instructions for proper testing. " Make sure the analyzer is sitting on a flat, stable surface. Do not perform testing with the analyzer held in the hand. " After inserting the test strip(s), do not move the analyzer until testing is complete and the test strip is removed. " As stated in the instructions for use, if an unexpected test result is given, the test should be repeated. There is no need to return or destroy the product. 2. Distributors should immediately forward this notice 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. If you have any questions, please contact Karmen Mercer, Director of Global Customer Care directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or (U.S. toll-free) 877-570-8610.
Quantity in Commerce67643 total
DistributionDomestic distribution nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CHH
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