DRG Sperm Ab ELISA Recalled for Potential False Negative Results
DRG International is recalling Sperm Ab ELISA kits due to a potential for false negative patient results. The recall covers 211 units distributed in the US and several international countries.
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 2/5 (Moderate).
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 Class II due to the potential for false negative patient results, which may lead to temporary or medically reversible adverse health consequences or a remote probability of serious consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
DRG International, Inc. is recalling 211 units of the Sperm Ab ELISA (Model/Catalog Number: EIA-1826). The recall is issued because of a potential for false negative patient results. The affected product is a 96-well plate test used for detecting sperm antibodies.
The recalled product was distributed nationwide in the United States, specifically in the state of New Jersey, as well as in Azerbaijan, Belgium, the Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, and Ukraine. The specific lot number is 320K046, and the UDI is 04048474018264.
Healthcare providers and laboratories should stop using the affected product immediately. Users should contact DRG International for instructions on how to return the product or obtain a replacement. Patients who have received test results using this specific lot should consult their healthcare provider to discuss the potential impact of false negative results.
The recalled product
- Product
- Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);
- Manufacturer
- DRG International, Inc.
- Hazard
- Affected units
- 211
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)
- Model/Catalog Number: EIA-1826
- UDI: 04048474018264
- Lot# 320K046
Distribution
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