DiaSorin Recalls PRO-Trac II Tacrolimus ELISA Kits Due to Instability
DiaSorin is recalling 451 PRO-Trac II Tacrolimus ELISA kits because instability may cause falsely elevated patient 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. The hazard involves a risk of harm (falsely elevated results affecting patient management) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DiaSorin Inc. is recalling 451 units of the PRO-Trac II Tacrolimus ELISA kit, reference numbers 32400 and 32400-CN. The affected lots are identified by codes 131716, 131716A, 131716B, 131716C, 131716D, 131716E, and 131717. The product is an in vitro reagent system used to measure tacrolimus levels in human blood to aid in the management of liver transplant patients.
The recall was initiated due to instability in the kit, which may cause falsely elevated patient results. This issue could potentially impact the clinical management of patients receiving tacrolimus therapy.
The affected kits were distributed worldwide, including in the United States (California) and in China, Belgium, Argentina, and India. Healthcare facilities and laboratories should stop using the affected kits and contact DiaSorin Inc. for instructions on return or replacement.
The recalled product
- Product
- DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized…
- Manufacturer
- Diasorin Inc.
- Affected units
- 451
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 (7)
- 131716
- 131716A
- 131716B
- 131716C
- 131716D
- 131716E
- 131717.
Distribution
Distributed in 1 state:
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