The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s...
Reason for Recall / Hazard
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Product Description & Identification
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Affected Products
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Additional Source Details
| Field | Value |
|---|---|
| City | Indianapolis |
| State | IN |
| Event id | 98103 |
| Address 1 | 9115 Hague Rd |
| Code info | 08496633190 lot 840183 exp. 02/26 08496633190 lot 874011 exp. 10/26 08496609190 lot 840177 exp. 05/26 |
| Postal code | 46256-1025 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 1300 cassettes |
| Reason for recall | Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251121 |
| Initial firm notification | Letter |
| Center classification date | 20260102 |
Overview
- Recalling FirmRoche Diagnostics Operations, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI, MN, NC, NJ, NM, NY, OH, PA, PR, TN, TX, UT, WA, WV.