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.
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 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.
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