FDAClass IIJanuary 13, 2016

Siemens Acute Care BHCG CalPak-in vitro diagnostic recall

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…

Why was Siemens Acute Care BHCG CalPak-in vitro diagnostic recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 625229002

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…
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
196
Distribution
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.
Recall date
January 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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