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U.S. Department of Health and Human Services

Class 2 Device Recall MSH6 (44) Mouse Monoclonal Antibody

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 Class 2 Device Recall MSH6 (44) Mouse Monoclonal Antibodysee related information
Date Initiated by FirmMay 27, 2021
Create DateJuly 21, 2021
Recall Status1 Terminated 3 on April 05, 2024
Recall NumberZ-2106-2021
Recall Event ID 88072
Product Classification Reagents, specific, analyte - Product Code MVU
Product Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Code Information Lot Number: 0000101423
Recalling Firm/
Manufacturer		 Cell Marque Corporation
6600 Sierra College Blvd
Rocklin CA 95677-4306
For Additional Information ContactTechnical Services
1800-665-7284 Ext. 1
Manufacturer Reason
for Recall		Product distributed for use as an In-vitro Diagnostics without FDA clearance
FDA Determined
Cause 2		Process control
ActionOn May 27, 2021, Cell Marque Corporation issued a "Recall Notification" via e-mail to all affected consignee. On June 15, 2021 the firm issued a "Urgent Medical Device Recall Notification" to provide additional information. This communication was sent via e-mail. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. 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. 2.Cell Marque is requesting that you destroy any unused or partially used containers of the products and that you provide us with confirmation that the product has been destroyed. If you have already used all the products, please confirm that the product has been used and is no longer available. Please complete the Attachment 1 confirmation of receipt form and return to local contact indicated below. 3. In addition, if you may have further distributed the product, please identify your customers and notify them of this issue immediately. Your notification to customers should include a copy of this notification. 4. Technical Services: Toll free at 800.665.7284 | Press 1. Additionally, email us at CellMarqueTS@milliporesigma.com 5. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce2 units
DistributionUS: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
Total Product Life CycleTPLC 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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