Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages
Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to provide results, which poses a risk of harm (inaccurate glucose monitoring) even though specific injuries are not reported in the source text.
Plain-English summary
Nova Biomedical Corporation is recalling 2,200 cases of Nova StatStrip Xpress Glu-Test Strips (Catalog # 51493, UK Only). The recall affects Lot 0312361309 (Expires 6/30/2015) and Lot 0313021309 (Expires 07/31/2015). The product was distributed worldwide, including nationwide in the United States (specifically CA, IL, KY, NY, and WV) and in the United Kingdom and Italy.
The recall was initiated because the glucose test strips report a 'no result' message when tested. This defect prevents the device from providing a valid glucose reading. The agency has classified this as a Class II recall.
Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for a refund or replacement. Users should verify the lot number and expiration date on their packaging to determine if their product is affected.
The recalled product
- Product
- Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
- Manufacturer
- Nova Biomedical Corporation
- Affected units
- 2,200
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 (3)
- Lot 0312361309
- Expires 6/30/2015 Expanded recall: Lot 0313021309
- Expires 07/31/2015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nova Biomedical 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.
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