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U.S. Department of Health and Human Services

Class 2 Device Recall ST AIAPACK PROG II

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  Class 2 Device Recall ST AIAPACK PROG II see related information
Date Initiated by Firm February 13, 2018
Create Date March 01, 2018
Recall Status1 Terminated 3 on October 29, 2020
Recall Number Z-0825-2018
Recall Event ID 79176
Product Classification Radioimmunoassay, progesterone - Product Code JLS
Product ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
Code Information All lots
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Danielle Konfal
614-277-4748
Manufacturer Reason
for Recall		 Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.
FDA Determined
Cause 2		 Device Design
Action The assays identified in the above table must not be used to report results for patients who are taking DHEA supplements. " For patients that are taking DHEA supplements, an alternative testing method which is not expected to show cross reactivity to DHEA-S should be used such as Liquid Chromatography-Mass Spectroscopy (LCMS). " Please review the information in this Urgent Medical Device Recall with your Medical Director and/or Lab Director, as soon as possible. " Continue to use the Progesterone Assays for patients who are not receiving DHEA supplements or therapy. " Complete and return the attached Urgent Medical Device Recall Acknowledgement Form within 15-days. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at 1(800) 248-6764 or email Bernadette.OConnell@tosoh.com. " Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at 1(800) 248-6764, or by email at Bernadette.OConnell@tosoh.com. We will be available to answer any questions Monday - Friday, from 8:00 AM to 5:00 PM (PST).
Quantity in Commerce 5579
Distribution Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
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.
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