Estrone RIA Diagnostic Kit Recall by Immunotech A.S.
Immunotech A.S. is recalling 160 Estrone RIA kits (REF: DSL8700) that may rarely give falsely high patient results, which could cause temporary injury with remote probability.
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: This is an FDA Class II recall. The hazard involves falsely high patient results that could cause temporary injury, but the source states the probability is remote and no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Immunotech A.S. is recalling 160 units of the Estrone RIA diagnostic kit, reference DSL8700. The recall affects two lot numbers: 251013C (expiration 2025-12-30) and 251110C (expiration 2026-01-27), identified by UDI 15099590211615.
The affected kits may rarely give falsely high patient results, which might cause temporary injury of remote probability. The issue is stated to occur only in very rare cases.
The product was distributed worldwide, including US nationwide distribution in the state of North Carolina, and internationally to Germany, Argentina, the Netherlands, Hungary, Austria, Belgium, France, and Italy.
Healthcare facilities and laboratories using the Estrone RIA kit should discontinue use of the affected lots and contact Immunotech A.S. for replacement or further instructions. Consumers or institutions with questions should follow their recall notification procedures.
The recalled product
- Product
- Estrone RIA, REF: DSL8700
- Manufacturer
- Immunotech A.S.
- Affected units
- 160
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)
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30)
- 251110C(2026-01-27)
Distribution
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