Recall Z-0875-06 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.
| Date | May 19, 2006 (initiated Apr 3, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 3229 cartons of 100 TestPaks |
| Distribution | Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK Dade Behring, Inc., Jan 13, 1999 |