| Class 3 Device Recall Collagen Reagent | |
Date Initiated by Firm | May 23, 2018 |
Create Date | November 22, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0537-2020 |
Recall Event ID |
83930 |
510(K)Number | K910706 |
Product Classification |
Reagent, platelet aggregation - Product Code GHR
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Product | Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use, |
Code Information |
Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369 |
Recalling Firm/ Manufacturer |
Helena Laboratories, Corp. 1530 Lindbergh Dr Beaumont TX 77707-4131
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For Additional Information Contact | Dr. Jessica Jones Hanka 409-842-3714 Ext. 1177 |
Manufacturer Reason for Recall | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth. |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | On 05/23/2018, the firm's technical services contacted consignees via phone call with a email follow-up of their recall notification letter. Consignees were advised of the following:
1. Prevent any shipment or schedule demonstrations with these lots
2. Remove the lots from available inventory and discard COLLAGEN vials.
3. Verify amount REMOVED FROM STOCK
4. COMPLETE THE FORM AND RETURN TO HELENA LABORATORIES, USA VIA: fax: 409-842-1874 OR E-MAIL TO JJONES@HELENA.COM. For questions, contact Jessica W. Jones, MD, MPH - Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177 |
Quantity in Commerce | 64 Aggregation Kits |
Distribution | US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ
OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GHR
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