Pointe Scientific Creatinine Reagent Recall Due to Labeling Error
Pointe Scientific is recalling 93 kits of Creatinine Reagent C7539-150 because the R1 and R2 reagent bottles are mislabeled, which prevents valid test results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a labeling error that prevents valid test results rather than causing direct physical harm.
Plain-English summary
Pointe Scientific, Inc. is recalling 93 kits of the Creatinine Reagent, catalog number C7539-150. The recall involves lot 406201, batch 279, with an expiration date of March 2016. The kits were distributed worldwide, including in the United States, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and the Philippines.
The recall was initiated because the reagent bottles within the kits are mislabeled. Specifically, the Creatinine reagent R1 is labeled as R2 (30ml), and the reagent R2 vial is labeled as R1 (120ml). This labeling error affects the manual procedure, as the control will be out of specifications, resulting in no valid test results being reported.
Users of the affected kits should stop using the product and contact Pointe Scientific for further instructions. The mislabeling does not indicate a safety hazard such as injury or illness, but rather a functional defect that prevents the diagnostic test from working correctly.
The recalled product
- Product
- Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
- Manufacturer
- Pointe Scientific, Inc.
- Hazard
- Affected units
- 93
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)
- C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Pointe Scientific, Inc.
See all →- LowPointe Scientific autoHDL Reagent Recalled Due to Potential Crystals
FDA (Devices) · 2015-09-23
- ModeratePointe Scientific Recalls G6PD Controls Due to Reduced Stability
FDA (Devices) · 2015-09-09
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 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
- LowMedtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch
FDA (Devices) · 2017-07-05
- LowPointe Scientific autoHDL Reagent Recalled Due to Potential Crystals
FDA (Devices) · 2015-09-23
- ModerateFentanyl Reagent Kit Recalled for Mislabeling as Clinical Diagnostic
FDA (Devices) · 2020-04-29
- ModerateSentinel CH Recalls MULTIGENT Creatinine Reagents Due to Quality Control Issues
FDA (Devices) · 2017-08-09
- LowMedtest Recalls Pointe Scientific Chemistry Controls Due to Mean Assignment Error
FDA (Devices) · 2017-05-31
- LowMedtest Holdings Recalls Pointe Scientific Hitachi AST Reagent Due to Labeling Discrepancy
FDA (Devices) · 2017-05-24