Cell Marque Recalls H. pylori Reagent Due to Missing Export Labeling
Cell Marque is recalling five units of H. pylori reagent because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and labeling issue (missing 'For Export Only' label) rather than a product defect or safety hazard, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Cell Marque Corporation is recalling five units of H. pylori (polyclonal) 1.0 mL reagent, catalog number 215A-76. The product is an in vitro diagnostic reagent intended for hematology use. The specific lot affected is 1611307C, with an expiration date of 2019-03.
The recall was initiated because the product was intended to be sold outside the United States but was not properly labeled as "For Export Only." This labeling failure violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
The affected units were distributed nationwide to facilities in California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, and Texas. Consumers and healthcare facilities should stop using the product and contact Cell Marque Corporation for further instructions.
The recalled product
- Product
- H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 5
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 (2)
- 1.0 ml lot 1611307C
- expiry 201 9-03.
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 Adenovirus Reagents Due to Export Labeling Error
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- HighCell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling
FDA (Devices) · 2021-08-25
- ModerateFentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic
FDA (Devices) · 2020-04-29
- HighCell Marque MSH6 Antibody Recalled for Distribution Without FDA Clearance
FDA (Devices) · 2021-07-28
- ModerateBiocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots
FDA (Devices) · 2015-05-06
- LowBD FMC7 FITC Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2016-03-02
- LowPointe Scientific Creatinine Reagent Recall Due to Labeling Error
FDA (Devices) · 2015-09-23