Cell Marque Corporation Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Brand
Cell Marque Corporation
Lot Codes / Batch Numbers
Lot Number: 0000101423
Products Sold
Lot Number: 0000101423
Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 008416831 due to Product distributed for use as an In-vitro Diagnostics without FDA clearance. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, FL, HI, ID, IL, KY, MN, MT, NH, NY, NC, PA, SC, VA, WI
Page updated: Jan 10, 2026