ADVIA Centaur Systems Progesterone Kit recall
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Why was ADVIA Centaur Systems Progesterone Kit recalled?
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
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: 42564268 42621268 43834268 Exp. Date: May 22, 2015
- Product
- ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Quantity
- 9778 kits
- Distribution
- Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and Vatican.
- Recall date
- March 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)