IMx HAVAB Controls In Vitro Test
FDA Recall Z-0660-05 · Posted 2005-03-29
Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeLOL
Date Initiated2005-03-04
Date Terminated2005-09-29
Product Quantity373 Kits
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.