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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 July 05, 2017
Create Date January 18, 2018
Recall Status1 Terminated 3 on October 04, 2018
Recall Number Z-0387-2018
Recall Event ID 78752
510(K)Number K161899  K133404  
Product Classification System, test, radioallergosorbent (rast) immunological - Product Code DHB
Product Phadia 1000 Instrument, Article Number 12-3800-01.
Code Information All versions of the instrument
Recalling Firm/
Manufacturer		 Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
For Additional Information Contact
269-833-1819
Manufacturer Reason
for Recall		 The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
FDA Determined
Cause 2		 Device Design
Action The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.
Quantity in Commerce 70 units
Distribution Nationwide
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
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