Siemens Acute Care" CCRP TestPak-in vitro diagnostic recall
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer…
Why was Siemens Acute Care" CCRP TestPak-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 Number: 425229002
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 78
- 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)