EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
FDA device recall Z-1174-2007 · posted 2007-08-22 · Terminated
Recall details
- Recalling firm
- Dade Behring, Inc.
- Reason for recall
- Sample ID and Patient results could be associated with the wrong patient
- Action taken
- The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 72 units
- Distribution
- Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.
- Date initiated
- 2007-07-03
- Date posted
- 2007-08-22
- Date terminated
- 2007-11-07
- 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 |
|---|---|---|
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |