Recall Z-1498-2022 ยท JIY Photometric Method, Iron (Non-Heme)
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
| Date | Jun 28, 2022 |
| Status | Open, Classified |
| Reason | Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test. |
| Root cause | Under Investigation by firm |
| Action | Siemens issued Urgent Medical Device Correction (UMDC) Letter by FedEx beginning on 06/28/2022. Letter states reason for recall, health risk and action to take: For customers operating with Atellica Software v.1.25.2 and lower, the resolution of this issue will be implemented in Atellica Software v1.25.3 which will be available soon. In the interim, please follow the instructions in the Additional Information section. Customers who are operating with Atellica Software v1.26 will receive further information when a software update to resolve the issue is available. For laboratories operating w |
| Quantity | 1614 units US ; 7,979 units OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, BR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, IE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, QA, KR, RO, RU, SA, R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., Jun 30, 1999 |