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U.S. Department of Health and Human Services

Class 2 Device Recall SigmaAdlrich, Harleco, Schiff Reagent, HotchkissMcManus

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  Class 2 Device Recall SigmaAdlrich, Harleco, Schiff Reagent, HotchkissMcManus see related information
Date Initiated by Firm January 26, 2024
Date Posted February 23, 2024
Recall Status1 Open3, Classified
Recall Number Z-1185-2024
Recall Event ID 93890
Product Classification Reagent, schiff - Product Code HZT
Product Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Code Information Part number: 6073-71, 500mL; Lot Numbers (Expiration Date): 3094 (2025-08-04), 3096 (2025-06-28);
Recalling Firm/
Manufacturer		 EMD Millipore Corporation
400 Summit Dr
Burlington MA 01803-5258
For Additional Information Contact Karen Russell
856-423-6300
Manufacturer Reason
for Recall		 This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
FDA Determined
Cause 2		 Material/Component Contamination
Action An URGENT MEDICAL DEVICE RECALL NOTIFICATION LETTER, DATED 26 January 2024 was sent to customers. Required/Recommended Action Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. Please discard this material and request a refund. Please complete attachment 1 form acknowledging receipt of this letter and return to the noted email address. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this issue. Your notification to customers should include a copy of this notification. You may contact Technical or Customer Service to discuss an appropriate solution for your needs at 1-800-221-1975 or 1-800-325-3010 or 1-800-645-5476. If you would like more information about this customer notification, please contact your local representative or use the link www.sigmaaldrich.com/offices for our website to obtain the phone number and/or email address of your local office.
Quantity in Commerce 106 Units (25 US, 81 OUS)
Distribution Domestic: AL, IL, MA, MN, NJ, PA, TX, VA. Foreign: Canada.
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 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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