Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic.
- Company
- Dade Behring Inc.
- Recall Initiated
- April 3, 2006
- Posted
- May 19, 2006
- Terminated
- August 7, 2006
- Recall Number
- Z-0884-06
- Quantity
- 194 cartons of 5 DilPaks
- Firm Location
- Newark, DE
Reason for Recall
Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
Distribution
Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
Lot / Code Info
Lot # 816023002
Root Cause
Other
Action Taken
Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.