Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance
Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or adverse health effects. The hazard is regulatory non-compliance (lack of FDA clearance) rather than a known safety defect. Per the rubric, theoretical hazards without reported harm score at most 3; this regulatory/procedural issue is appropriately scored at 2.
Plain-English summary
Cell Marque Corporation has recalled 41 kits of its RabMAb CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody (catalog number 117R-18) because the product was distributed for use as an in-vitro diagnostic without FDA clearance.
In-vitro diagnostic devices require FDA authorization before distribution in the United States. This product was marketed and distributed prior to obtaining the required FDA clearance or approval.
The affected product was distributed to customers in Alabama, Arizona, Arkansas, California, Florida, Hawaii, Idaho, Illinois, Kentucky, Minnesota, Montana, North Carolina, New Hampshire, New York, Pennsylvania, South Carolina, Virginia, and Wisconsin. Affected lot numbers are 0000058081 (expiration 31 December 2021), 0000072580 (expiration 30 September 2021), 0000090505 (expiration 30 September 2022), and 0000121052 (expiration 31 May 2023).
Customers who have received this product should contact Cell Marque Corporation for instructions regarding return or destruction of the recalled product.
The recalled product
- Product
- Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
- Manufacturer
- Cell Marque Corporation
- Hazard
- regulatory-non-compliance
- uncleared-medical-device
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 (4)
- Lot Numbers: 0000058081/ Exp: 31 Dec 2021
- 0000072580/ Exp: 30 Sep 2021
- 0000090505/ Exp: 30 Sep 2022
- 0000121052/ Exp: 31 May 2023
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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