FDA (Devices) recall action 72570
The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc is recalling 192 units of Acute Care MYO DilPak in vitro diagnostic products because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc is recalling 608 units of Acute Care MYO TestPaks because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc is recalling 1,157 Acute Care pBNP TestPaks because their barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics is recalling 1,051 units of Acute Care CKMB TestPaks because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.
Siemens Healthcare Diagnostics Inc is recalling 5,558 units of the Acute Care CTNI TestPak because barcode labels may not scan on Stratus CS systems.