| Class 2 Device Recall PTS Panels CHOLGLU Test Strips |  |
Date Initiated by Firm | March 14, 2018 |
Create Date | April 28, 2018 |
Recall Status1 |
Terminated 3 on September 13, 2018 |
Recall Number | Z-1543-2018 |
Recall Event ID |
79778 |
510(K)Number | K041750 |
Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
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Product | PTS Panels CHOL+GLU Test Strips (REF 1765) |
Code Information |
Lot # A705 UDI (01)00381931765016(17)180813(10)A705 |
Recalling Firm/ Manufacturer |
Polymer Technology Systems, Inc. 7736 Zionsville Rd Indianapolis IN 46268-2175
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For Additional Information Contact | Heidi Hancock Strunk 317-870-5610 |
Manufacturer Reason for Recall | Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) |
FDA Determined Cause 2 | Under Investigation by firm |
Action | 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. |
Distribution | OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NBW
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