Stratus CS STAT Fluorometric Analyzer Acute Care cTnI TestPak (CCTNI) in vitro diagnostic.
FDA Recall Z-0876-06 · Posted 2006-05-19
Recalling FirmDade Behring , Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2006-04-03
Date Terminated2006-08-07
Product Quantity10843 cartons of 100 TestPaks
Reason for Recall
Foil sealing of the TestPak 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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.