Recall Z-2086-2025 ยท KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Siemens Healthcare Diagnostics, Inc.
ADVIA 120/2120/2120i SETpoint Calibrator
| Date | Jul 3, 2025 (initiated Jun 4, 2025) |
| Status | Open, Classified |
| Reason | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification dated 6/4/25 was mailed to consignees. This notification provides consignees with calibration instructions given the issue found in affected lots. Additionally, instructions are given on how to proceed with product depending on performance. Consignees are to discontinue use of and discard of the calibrator SETPOINT lots impacted by this recall. Consignee locations are to review the provided notification with their Medical Directors to determine the appropriate course of action. A copy of the recall notification should be retained in laboratory r |
| Quantity | 2,020 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K840261 | CAL-CHEX, A HEMATOLOGY CALIBRATOR Streck Laboratories, Inc., Feb 21, 1984 |