Atellica Ch Enzymatic Hemoglobin A1c (a1c_e)
- Recalling firm
- Siemens Healthcare (NZ) Ltd
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E). [Device]. Affected: All in-date lots
- Reason
- The manufacturer has confirmed, through internal investigation of customer complaints, the potential for intermittent well-to-well bias affecting the A1c_E/A1c_H assay when used on the Atellica CH and Atellica CI systems. This observed bias does not affect every A1c_E reagent lot or reagent pack. However, affected wells cannot currently be identified prospectively, therefore all in-date lots are considered potentially impacted until further notice. Under certain circumstances, this problem may result in:, 1. Falsely depressed patient results when lot calibration is performed using an...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-06-11
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/40cf8811-f523-4126-a826-07b2a61c7459