H. Pylori Diagnostic Test Recalled Due to Incorrect Expiration Date Label
Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.
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: FDA Class II recall of a diagnostic device with mislabeled expiration date. No reported illnesses or injuries, but use of expired product may produce false test results, constituting a risk of harm to patient diagnostic accuracy. The hazard is theoretical rather than documented.
Plain-English summary
Immunostics, Inc. is recalling Detector H. Pylori test kits (Catalog Number IHP-30) due to an expiration date labeling error. Affected product lots are labeled with an expiration date of October 31, 2023, but the correct expiration date is October 31, 2022.
The product was distributed to California and Missouri. Healthcare providers and laboratories using affected lots (0821132-2, 0821132-3, 0821132-4) should stop using these kits immediately.
Using an expired diagnostic test may result in false positive results, false negative results, or invalid test outcomes, which could lead to incorrect patient diagnosis or treatment decisions. Affected facilities should verify their inventory against the recalled lot numbers and contact Immunostics for replacement product or refunds.
The recalled product
- Product
- Detector H. Pylori, Catalog Number IHP-30
- Manufacturer
- Immunostics, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 10
Distribution
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