Dade(R) Actin(R) FSL Activated PTT Reagent. For use in recall
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Why was Dade(R) Actin(R) FSL Activated PTT Reagent. For use in recalled?
Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
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 numbers B4219-1 and B4219-2: lot numbers 547311, exp 3/22/2013; 547312, exp 3/22/2013 and 547316A, exp 4/28/2013.
- Product
- Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 13,083
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and Puerto Rico and the country of Canada.
- Recall date
- April 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)