Pointe Scientific Recalls G6PD Controls Due to Reduced Stability
Pointe Scientific is recalling G6PD Controls due to reduced reconstituted stability that may cause out-of-specification results.
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: The recall is classified as FDA Class II, but the hazard is limited to potential out-of-specification test results due to reduced stability, with no reported injuries or illnesses, fitting the Moderate criteria for low-risk quality issues.
Plain-English summary
Pointe Scientific, Inc. is recalling G6PD Controls (Glucose-6-phosphate dehydrogenase) due to a reduction in reconstituted stability. The affected product is sold in kits containing six 0.5 ml vials (two vials each of Level 1, Level 2, and Level 3) or as individual vials. The total quantity involved is 2,772 vials, comprising 374 kits and 528 individually sold vials.
The recall is driven by a quality issue where clinicians may notice a drop in recovery of the control after reconstitution. This instability could result in out-of-specification test results prior to the current reconstitution claim of 7 days. The affected lot number is 505801, with an expiration date of November 2015. Catalog numbers include G7583-CTL, 7-G7583-CTL-L1, 7-G7583-CTL-L2, and 7-G7583-CTL-L3.
The product was distributed worldwide, including nationwide in the United States (specifically PA, CA, KY, FL, NJ, DE, MI, MN, and IL) and in the United Arab Emirates, Austria, Italy, Israel, Greece, and Australia. Users are advised to discontinue use of the control set.
The recalled product
- Product
- Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be
- Manufacturer
- Pointe Scientific, Inc.
Distribution
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