ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239
This recall has been terminated (originally issued February 13, 2018).
- Company
- Tosoh Bioscience Inc
- Recall Initiated
- February 13, 2018
- Terminated
- October 29, 2020
- Recall Number
- Z-0825-2018
- Quantity
- 5579
- Firm Location
- Grove City, OH
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All lots
Root Cause
Device Design
Action Taken
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).