Recall Z-0660-05 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Abbott Health Products, Inc.
IMx HAVAB Controls In Vitro Test
| Date | Mar 29, 2005 (initiated Mar 4, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 373 Kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.