QIAGEN Recalls EZ1 DSP Virus Kit Due to Underfilled Reagent Wells
QIAGEN is recalling 287 units of the EZ1 DSP Virus Kit (48) because underfilled reagent wells could lead to incorrect diagnostic 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: The recall is classified as FDA Class II and involves a risk of incorrect diagnostic results, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
QIAGEN is recalling 287 units of the EZ1 DSP Virus Kit (48), IVD, REF 62724. The recall is due to underfilled reagent wells, which could lead to incorrect in vitro diagnostic results.
The affected products are identified by UDI 04053228000099, Lot 160020069, and an expiration date of 11/01/19. The agency has classified this as a Class II recall. The products were distributed domestically in Maryland and internationally in AE, AU, CZ, DE, DZ, ES, FR, GB, HK, IE, IT, NO, RO, and SA.
Users of these kits should stop using the affected units and contact QIAGEN for further instructions or a replacement.
The recalled product
- Product
- EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
- Manufacturer
- QIAGEN
- Hazard
- Affected units
- 287
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 (1)
- UDI - 04053228000099 Lot - 160020069 Expiration - 11/01/19
Distribution
Distribution scope not specified by the agency.
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