FDA Devices recall · Reported January 21, 2015
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.
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 mism…
Phadia US Inc recalled Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instr… - a moderate-severity action.
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instr… was recalled by Phadia US Inc in January 21, 2015. Reason: During an investigation of instrument logs it was determined that In specific circumstances involving multipl…. Check the official notice for the remedy. Verify recall #Z-0947-2015 with the FDA Devices before acting.
The recall
Phadia US Inc issued this moderate-severity FDA Devices recall-During an investigation of instrument logs it was determined that In specific circumstances involving multipl….
- Moderate
- severity level
- 146 units
- affected scope
- Class II
- classification
- January 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0947-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0947-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on November 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Phadia US Inc is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 146.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0947-2015 |
| Date reported | January 21, 2015 |
| Date initiated | November 20, 2014 |
| Recalling firm | Phadia US Inc |
| Firm location | Portage, MI |
| Affected scope | 146 |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0947-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026