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.
device · product 1 of 9
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.
Devices were delivered without the required dry ice.
Code information
LN 1L76-01; Lot 46K15718
Distribution pattern
Distribution to Latvia.
device · product 2 of 9
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
Devices were delivered without the required dry ice.
Code information
LN 4P72-01; Lot 902920500
Distribution pattern
Distribution to Latvia.
device · product 3 of 9
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Devices were delivered without the required dry ice.
Code information
LN 8K25-12; Lot 01018I000
Distribution pattern
Distribution to Latvia.
device · product 4 of 9
ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
Devices were delivered without the required dry ice.
Code information
LN 8K25-04; Lot 01018H000
Distribution pattern
Distribution to Latvia.
device · product 5 of 9
ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Devices were delivered without the required dry ice.
Code information
LN 3P25-11; Lot 94347UIOO
Distribution pattern
Distribution to Latvia.
device · product 6 of 9
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma with the ARCHITECT STAT High Sensitive Troponin-I reagent kit.
Devices were delivered without the required dry ice.
Code information
LN 3P25-02; Lot 93284UIOO
Distribution pattern
Distribution to Latvia.
device · product 7 of 9
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
Devices were delivered without the required dry ice.
Code information
LN 09P3501; Lot 84347UN18
Distribution pattern
Distribution to Latvia.
device · product 8 of 9
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Devices were delivered without the required dry ice.
Code information
LN 5P78-10; Lot 18004181
Distribution pattern
Distribution to Latvia.
device · product 9 of 9
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
