Recall Z-1252-2022 · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
| Date | Apr 13, 2022 |
| Status | Open, Classified |
| Reason | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results |
| Root cause | Under Investigation by firm |
| Action | Siemens issued an Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 04/13/2022 and an Urgent Field Safety Notice (UFSN) was issued to all OUS. Letter states reason for recall, health risk and action to take: If your facility has multiple lots of T3 available for use and some kit lots are below lots ending in 244, follow the steps below to ensure that T3 results will be correct for all available lots until all kit lots available for use are kit lots ending in 244 or above. Ensure that all IM modules connected to an Atellica Solution have only 1 lot of T3 re |
| Quantity | 1,566 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, |
| 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 |