IMx HAVAB Controls In Vitro Test
- Company
- Abbott Health Products, Inc.
- Recall Initiated
- March 4, 2005
- Posted
- March 29, 2005
- Terminated
- September 29, 2005
- Recall Number
- Z-0660-05
- Quantity
- 373 Kits
- Firm Location
- Barceloneta, PR
Reason for Recall
Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
Distribution
The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore. There are US Government accounts.
Lot / Code Info
Lot # 21059Q100 Expiration Date: May 20, 2005
Root Cause
Other
Action Taken
Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.