Dimension Vista(R) Systems Vista(R) Theophylline THEO recall
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the…
Why was Dimension Vista(R) Systems Vista(R) Theophylline THEO recalled?
Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
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?
Lots 12135AE and 12171BB
- Product
- Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 959 cartons
- Distribution
- USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
- Recall date
- November 28, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)