RecallRadar

FDA Device recall Z-2106-2021

Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

On 2021-07-28 the FDA classified a Class II recall of Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513 by Cell Marque, citing product distributed for use as an In-vitro Diagnostics without FDA clearance.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2106-2021
ClassificationClass II
Statusterminated
Initiated2021-05-27
Published2021-07-28
Last updated2026-09-13 11:56 UTC
CompanyCell Marque
DistributionAL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI

Product

Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

Reason

Product distributed for use as an In-vitro Diagnostics without FDA clearance

Identifiers

code_infoLot Number: 0000101423

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2106-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.