Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic.
FDA device recall Z-0880-06 · posted 2006-05-19 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHA
- Quantity affected
- 1151 cartons of 5 DilPaks
- Distribution
- Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
- Date initiated
- 2006-04-03
- Date posted
- 2006-05-19
- Date terminated
- 2006-08-07
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD (K003696) | Dade Behring, Inc. | 2001-01-25 |