Recall Z-0825-2018 ยท JLS Radioimmunoassay, Progesterone
Tosoh Bioscience Inc
ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239
| Date | Feb 13, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 a |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.