Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages
Nova Biomedical 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. The hazard involves a functional defect in a medical device used for monitoring a chronic condition, which poses a risk of harm (inaccurate monitoring) even though specific injuries are not reported in the source text.
Plain-English summary
Nova Biomedical Corporation is recalling 7,433 cases of Nova StatStrip Xpress Glu-Test Strips (Catalog # 42214). The recall involves specific lots with expiration dates of 12/31/2014, 06/30/2015, and 07/31/2015. The affected test strips may report a 'no result' message when used for glucose testing.
The product was distributed worldwide, including nationwide in the United States (specifically noting CA, IL, KY, NY, and WV) and in the United Kingdom and Italy. This is an expanded recall that includes additional lots beyond the initial scope.
Consumers should stop using the affected test strips and contact Nova Biomedical Corporation for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
- Manufacturer
- Nova Biomedical Corporation
- Affected units
- 7,433
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 (4)
- Lot 0312349249
- Expires 12/31/2014 and Lot 0312361309
- Expires 06/30/2015 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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