Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random
FDA device recall Z-0581-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Dade Behring, Inc.
- Reason for recall
- Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.
- Action taken
- The recalling firm notified consignees by telephone to inform them of the problem. A follow-up letter, "Urgent Field Safety Notice" dated 9/30/08 was issued with information describing the problem, the possible impact of an occluded wash probe on assay results, and emphasizing regular performance of routine wash probe maintenance as detailed in the operator guide to prevent wash probe occlusion. For questions, please contact the Siemens Technical Solution Center at 800-441-9250.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 57 units
- Distribution
- Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.
- Date initiated
- 2008-09-30
- Date posted
- 2009-01-13
- Date terminated
- 2009-05-05
- 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 |
|---|---|---|
| DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD (K073604) | Dade Behring, Inc. | 2008-03-13 |