Cell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance
Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody because the product was distributed as an in-vitro diagnostic device without FDA clearance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for distribution of an in-vitro diagnostic device without FDA clearance. No injuries or illnesses have been reported, but an uncleared diagnostic product poses a risk of harm through potentially inaccurate diagnostic results, meeting the 'risk-of-harm' criterion in the rubric.
Plain-English summary
Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, Lot Number 0000101423, because the product was distributed for use as an in-vitro diagnostic device without FDA clearance.
The recalled product was distributed to healthcare facilities and laboratories in Alabama, Arizona, Arkansas, California, Florida, Hawaii, Idaho, Illinois, Kentucky, Minnesota, Montana, North Carolina, New Hampshire, New York, Pennsylvania, South Carolina, Virginia, and Wisconsin.
In-vitro diagnostic devices require FDA clearance prior to distribution to ensure they have been validated for safety and effectiveness in their intended use. This product was distributed without such clearance, constituting a regulatory violation.
The recalled product
- Product
- Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
- Manufacturer
- Cell Marque Corporation
- Hazard
- missing-fda-clearance
- unvalidated-diagnostic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 0000101423
Distribution
Distributed in 18 states:
- AL
- AR
- AZ
- CA
- FL
- HI
- ID
- IL
- KY
- MN
- MT
- NC
- NH
- NY
- PA
- SC
- VA
- WI
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