Quidel Recalls InflammaDry Sample Collectors Due to Plastic Spurs
Quidel Corporation is recalling InflammaDry sample collectors because in-house testing found plastic spurs at the tips of some units.
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, which typically indicates a temporary or medically reversible adverse health consequence. The defect involves physical spurs on sample collectors, which poses a risk of injury during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Quidel Corporation is recalling 1,078 kits and 21,560 sample collectors for the InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION. The recall was initiated after in-house testing revealed the presence of plastic spurs at the tips of some sample collectors.
The affected products are Lot numbers 1705405 and 1705359. These products were distributed nationwide, including in AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, and WV.
The InflammaDry test is a rapid, immunoassay used for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears to aid in the diagnosis of dry eye. It is intended for prescription use at point-of-care sites. The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these specific units.
The recalled product
- Product
- InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used t
- Manufacturer
- Quidel Corporation
- Category
- Medical Device — Diagnostic Test
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 (2)
- Lot numbers: 1705405
- 1705359
Distribution
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