CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
Pro-Trac II Tacrolimus Elisa kit recalled by Diasorin
Diasorin is recalling Pro-Trac II Tacrolimus Elisa kit, distributed in California. The recall was initiated on 16 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1464-2015
- FDA event ID
- 70773
- Recalling firm
- Diasorin, Stillwater, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2015
- FDA classified
- 20 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Mar 2015 | Recall initiated by company | |
| 20 Apr 2015 | Classified by FDA | +35 days |
| 29 Apr 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
Where it was distributed
Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
Questions about this recall
Why was it recalled?
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Which lots are affected?
131716, 131716A, 131716B, 131716C, 131716D, 131716E, 131717.
Where was it sold?
Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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