Z-1540-2018 Class II Terminated
FDA device recall Z-1540-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on Jan 30, 2018 and is designated Class II. Reason for recall: May produce erroneously low results from specific well sets. The recall status is terminated (terminated May 16, 2019). Affected quantity: 6000.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Jan 30, 2018
- Termination Date
- May 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6000
Product Description
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Reason for Recall
May produce erroneously low results from specific well sets.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
Code Information
Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1540-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026