openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
Code information
Device Listing No: D011443 Batch Number 16060BB
Distribution pattern
Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.
