PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.
FDA Recall Z-1132-2010 · Posted 2010-03-15
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Recalling FirmPolymer Technology Systems, Inc.
Recall StatusTerminated
Product CodeMRR
Date Initiated2008-05-29
Date Terminated2010-10-20
Product Quantitynot available.
Reason for Recall
The expiration date was extended by 20 weeks without justification.
Firm Action
An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records.
If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.
Root Cause
Process change control
Distribution Pattern
Worldwide distribution
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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