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U.S. Department of Health and Human Services

Class 3 Device Recall Pointe Scientific Chemistry Controls Level I and II

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  Class 3 Device Recall Pointe Scientific Chemistry Controls Level I and II see related information
Date Initiated by Firm May 15, 2014
Date Posted May 20, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-2121-2017
Recall Event ID 77083
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Pointe Scientific Chemistry Controls Level I and II

LEVl: Amber glass vial w/PP white plastic cap.
LEV2: Amber glass vial w/PP black plastic cap.
Code Information Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Cynthia M. Williams
734-487-8300
Manufacturer Reason
for Recall		 The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
FDA Determined
Cause 2		 Component design/selection
Action Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship. All product shipped after 05/15/2014 included the updated package inserts. Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific.
Quantity in Commerce 132919 Vol vials
Distribution Nationwide
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.
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