Recall Z-2405-2020 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
| Date | Jun 19, 2020 (initiated May 7, 2020) |
| Status | Open, Classified |
| Reason | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers. |
| Root cause | Employee error |
| Action | On May 7, 2020, Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction letter to their Atellica Solution IM1300/IM1600 Analyzer customers. The letter described the precautions to be taken when using the following sample containers: Atellica Tube Top Sample Cups - Siemens SMN 11069061 1mL, the Atellica Tube Top Sample Cups - Siemens SMN 11069062 2mL, and the Sarstedt 62.612 - 15.3 x 92 False Bottom sample tubes. The letter states the following about using any of the identified sample containers: the IM Analyzer has a minimum required sample volume for any reportable result; the |
| Quantity | 1329 |
| Distribution | Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tenn |
| 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 |