Recall Z-1300-2019 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer, Material Number 11066000
| Date | Mar 7, 2019 |
| Status | Terminated |
| Reason | There were multiple issues identified in the system software which required an update. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers. |
| Quantity | 366 |
| Distribution | The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System Siemens Healthcare Diagnostics, Inc., Nov 20, 2015 |