Turbo Troponin I For in vitro diagnostic use for the recall
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the…
Why was it recalled?
The source record does not provide a concise hazard summary.
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?
Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.
- Product
- Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3,622 kits (3,572 domestic and 50 internationally)
- Distribution
- Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.
- Recall date
- December 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)