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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72570

11 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 11, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics Inc

Dossier provenance

Source snapshots represented here

  • 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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

11 official enforcement rows

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 11

Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071

Z-0609-2016
Recall number
Z-0609-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
5558

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 2 of 11

Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

Z-0610-2016
Recall number
Z-0610-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
1157

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 215166002, 215194002, 215222002, 215271002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 3 of 11

Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic

Z-0611-2016
Recall number
Z-0611-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
2647

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 405131002, 405173002, 405187002, 405208002, 405229002 405278002, 405292002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 4 of 11

Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079

Z-0612-2016
Recall number
Z-0612-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
608

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 515146002, 515201002, 515285002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 5 of 11

Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

Z-0613-2016
Recall number
Z-0613-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
1051

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 245138002, 245152002, 245215002, 245262002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 6 of 11

Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066

Z-0614-2016
Recall number
Z-0614-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
78

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Number: 425229002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 7 of 11

Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060

Z-0615-2016
Recall number
Z-0615-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
590

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 445146002, 445201002, 445243002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 8 of 11

Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067

Z-0616-2016
Recall number
Z-0616-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
65

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 625229002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 9 of 11

Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061

Z-0617-2016
Recall number
Z-0617-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
196

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 625229002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 10 of 11

Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic

Z-0618-2016
Recall number
Z-0618-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
192

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 815131002, 815222002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.

device · product 11 of 11

Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070

Z-0619-2016
Recall number
Z-0619-2016
Initiated
November 11, 2015
Classification
Class II
Status
Terminated
Quantity
146

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Code information

Lot Numbers: 845173002

Distribution pattern

Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.