Z-0947-2015Class II

Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software...

Name: Z-0947-2015 Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software...
Creator: Phadia US Inc
Published: 2014-11-20
License: https://open.fda.gov/license/

Phadia AB / initiated 2014-11-20 / Terminated / root cause: software

FDA source

Phadia US Inc began a recall of Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP... on 2014-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0947-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Posted: 2015-01-12
Terminated: 2015-06-30
Recalling firm: Phadia AB
Product: 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.
Product code: DHB System, Test, Radioallergosorbent (Rast) Immunological
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.
Root cause tag: software
FDA root cause: Software design
Action: ThermoFisher sent an Urgent Medical Device Product Correction letter to all affected customers. The firm will inform customers of the specific sequence of errors and operator actions that can trigger the event via letter and phone, and will request that they do not respond to the Barcode Read Error and let the sample with the error eject normally from the instrument and be rerun after the barcode read error has been resolved. The firm will issue a mandatory Phadia 1000 Instrument Software (ISW) update that will correct the issue and make efforts to install it within 45 days from date of availability. Customers were asked to return the written response form via fax to: 1-888-243-5214 Attention: Customer Support, Phadia 1000 ISW Product Correction Response; EMAIL: [email protected] Email Subject Line: Phadia 1000 ISW Product Correction Response. Customers with questions were instructed to contact Phadia US Technical Support at 800-346-4364, option 2. For questions regarding this recall call269-492-1957.
Quantity in commerce: 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.
Product codes and lots: Part Number 12-3800-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0947-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0947-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12

Product code DHB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)