CLASS II Device recall · Reported 5 Dec 2012 · FDA Enforcement Report
The Is-anti-Sm test kits**** recalled by Diamedix
Diamedix is recalling The Is-anti-Sm test kits****, distributed nationwide in the US. The recall was initiated on 6 Aug 2012 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-0445-2013
- FDA event ID
- 63410
- Recalling firm
- Diamedix, Miami, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2012
- FDA classified
- 27 Nov 2012
- Reported
- 5 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Aug 2012 | Recall initiated by company | |
| 27 Nov 2012 | Classified by FDA | +113 days |
| 5 Dec 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
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
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Where it was distributed
Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
Nationwide CaliforniaFloridaIdahoNew JerseyNew YorkOhioPennsylvaniaPuerto RicoRhode IslandTennesseeTexas
Questions about this recall
Is The Is-anti-Sm test kits**** recalled?
Yes. Diamedix recalled The Is-anti-Sm test kits**** on 6 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0445-2013.
Why was it recalled?
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Which lots are affected?
Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
Where was it sold?
Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
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 21 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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|---|---|---|---|---|---|
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