Cell Marque Recalls Adenovirus Reagents Due to Export Labeling Error
Cell Marque is recalling Adenovirus reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and labeling issue (missing 'For Export Only' label) with no reported health hazards, injuries, or illnesses.
Plain-English summary
Cell Marque Corporation is recalling specific lots of Adenovirus (20/11 & 2/6) Analyte Specific Reagents. The affected products include the 0.5 mL size (Catalog # 212M-15) and the 7.0 mL size (Catalog # 212M-18). These are in vitro diagnostic reagents intended for microbiology use.
The recall was initiated because the company identified that the product, which was intended to be sold outside the United States, was not properly labeled as "For Export Only." This labeling failure violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.
The recall involves 12 units distributed nationwide to laboratories in California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, and Texas. Affected lots include 0.5 mL units with lot number 1318203P and expiry date 2018-04, and 7.0 mL units with lot numbers 1318204H 201 (expiry 8-04 11) and 1532111A (expiry 2018-10). Users should stop using these specific lots and contact Cell Marque for instructions.
The recalled product
- Product
- Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 12
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 (5)
- 0.5 mL - 1318203P
- Expiry 2018-04
- 7.0 mL - 1318204H 201
- Expiry 8-04 11 and 1532111A
- expiry 2018-10.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Cell Marque Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Cell Marque Corporation
See all →- HighCell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling
FDA (Devices) · 2021-08-25
- ModerateCell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance
FDA (Devices) · 2021-07-28
- HighCell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance
FDA (Devices) · 2021-07-28
- LowCell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling
FDA (Devices) · 2017-06-07
- LowCell Marque Recalls Herpes Simplex Virus II Reagents for Labeling Errors
FDA (Devices) · 2017-06-07
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02