Z-0660-05

IMx HAVAB Controls In Vitro Test

Name: Z-0660-05 IMx HAVAB Controls In Vitro Test
Creator: Abbott Health Products, Inc.
Published: 2005-03-04
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2005-03-04 / Terminated / root cause: labeling and UDI

FDA source

Abbott Health Products, Inc. began a recall of IMx HAVAB Controls In Vitro Test on 2005-03-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0660-05
Status: Terminated
Initiated: 2005-03-04
Posted: 2005-03-29
Terminated: 2005-09-29
Recalling firm: Abbott Diagnostic International, Ltd.
Product: IMx HAVAB Controls In Vitro Test
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot # 21059Q100 Expiration Date: May 20, 2005

Product code LOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)