CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
Phadia 1000 Instrument (introduced as UniCAP 1000) recalled by Phadia US
Phadia US is recalling Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All, distributed nationwide in the US. The recall was initiated on 20 Nov 2014 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-0947-2015
- FDA event ID
- 69872
- Recalling firm
- Phadia US, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2014
- FDA classified
- 12 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Nov 2014 | Recall initiated by company | |
| 12 Jan 2015 | Classified by FDA | +53 days |
| 21 Jan 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
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
Product as listed by the FDA
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
Where it was distributed
Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKansasMarylandMichiganMinnesotaNorth CarolinaNew JerseyNevadaNew YorkOhioOklahomaOregonPennsylvania
Questions about this recall
Is Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All recalled?
Yes. Phadia US recalled Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All on 20 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0947-2015.
Why was it recalled?
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
Which lots are affected?
Part Number 12-3800-01
Where was it sold?
Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
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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