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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Siemens Healthcare Diagnostics Inc: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Agency Publication Date: January 7, 2016
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Affected Products

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

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

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Product: 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

Lot Numbers: 215166002, 215194002, 215222002, 215271002

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

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

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

Lot Numbers: 515146002, 515201002, 515285002

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Product: 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

Lot Numbers: 245138002, 245152002, 245215002, 245262002

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Product: 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

Lot Number: 425229002

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Product: 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

Lot Numbers: 445146002, 445201002, 445243002

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Product: 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

Lot Numbers: 625229002

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Product: 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

Lot Numbers: 625229002

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

Lot Numbers: 815131002, 815222002

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Product: 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

Lot Numbers: 845173002

Lot Numbers:
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72570
Status: Resolved
Manufacturer: Siemens Healthcare Diagnostics Inc
Manufactured In: United States
Units Affected: 11 products (5558; 1157; 2647; 608; 1051; 78; 590; 65; 196; 192; 146)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.