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U.S. Department of Health and Human Services

Class 2 Device Recall Phadia 1000 Instrument

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  Class 2 Device Recall Phadia 1000 Instrument see related information
Date Initiated by Firm November 20, 2014
Date Posted January 12, 2015
Recall Status1 Terminated 3 on June 30, 2015
Recall Number Z-0947-2015
Recall Event ID 69872
510(K)Number K133404  K131738  K122197  K123275  K121463  K121156  
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
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.
Code Information Part Number 12-3800-01
Recalling Firm/
Manufacturer		 Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
For Additional Information Contact Martin R. Mann
269-492-1957
Manufacturer 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.
FDA Determined
Cause 2		 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: Compliance-us.idd@thermofisher.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DHB and Original Applicant = PHADIA AB
510(K)s with Product Code = DHB and Original Applicant = PHADIA US INC.
510(K)s with Product Code = DHB and Original Applicant = Thermo Fisher Scientific
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