IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls o
FDA device recall Z-0217-05 · posted 2004-11-20 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.
- Action taken
- Device recall letters were dated 10/27/2004. Letter was mail to customers asking to destroy and discontinue use of device. On hand inventory information was requested to be forward to Abbott at 1-800-777-0051 (U.S. only).
- Root cause
- Other
- Status
- Terminated
- Product code
- LOL
- Quantity affected
- 397 kits
- Distribution
- The product has been distributed to hospitals, laboratories and other institution including government accounts. Geographic areas of distribution include Puerto Rico, Canada, Germany, Thailand and U.S
- Date initiated
- 2004-10-27
- Date posted
- 2004-11-20
- Date terminated
- 2005-03-16
- Location
- Barceloneta, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.