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U.S. Department of Health and Human Services

Class 2 Device Recall EliA Sample Diluent, Article number, 83102301

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  Class 2 Device Recall EliA Sample Diluent, Article number, 83102301 see related information
Date Initiated by Firm January 30, 2017
Date Posted February 24, 2017
Recall Status1 Terminated 3 on August 07, 2017
Recall Number Z-1253-2017
Recall Event ID 76343
510(K)Number K061165  
Product Classification Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
Product EliA Sample Diluent, Article number, 83-1023-01
Code Information EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
Recalling Firm/
Manufacturer		 Phadia US Inc
4169 Commercial Ave
Portage MI 49002-9701
For Additional Information Contact Martin R. Mann
269-833-1819
Manufacturer Reason
for Recall		 Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
FDA Determined
Cause 2		 Under Investigation by firm
Action Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: ¿ Stop using the affected lots of the above mentioned product lots ¿ Please, return or attest to scrapping of any unused product lots to the manufacturer and order replacement products free of charge. ¿ Review your records to determine if you have had instrument problems due to deformed bottles. If you find the instrument error message 3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT Target 2, please collect all log files available and/or contact customer support, who will further assist in assessing possible impact on the test results in scope. ¿ Fill in the Medical Device Recall return response on page 3 and return to the manufacturer by e-mail. If customers have any questions, please contact Phadia US, Inc. at 1-800-346- 4364, option #2.
Quantity in Commerce 5957
Distribution Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
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 = NHX and Original Applicant = SWEDEN DIAGNOSTICS (US), INC.
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