Z-1657-2026 Class II Ongoing
FDA device recall Z-1657-2026 was initiated by Siemens Healthcare Diagnostics, Inc. on February 23, 2026 and is designated Class II. Reason for recall: A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall.… The recall status is ongoing. Affected quantity: 21,291 units (9750 US, 11541 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- February 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,291 units (9750 US, 11541 OUS)
Product Description
Reason for Recall
Distribution Pattern
Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia , Germany , Greece , Hong Kong, India, Iraq , Italy , Jordan , Kuwait , Latvia , Lithuania , Macedonia , Malaysia, Maldives, Mexico, Netherlands , New Zealand, Norway , Oman , Pakistan , Paraguay, Qatar , Romania , Saudi Arabia , Serbia , Singapore, Slovakia , Slovenia , South Africa, South Korea, Spain , Turkey , Turkmenistan , U.A.E. , Uganda , United Kingdom , Uruguay , Vatikancity;