Z-0217-05

IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive...

Name: Z-0217-05 IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive...
Creator: Abbott Health Products, Inc.
Published: 2004-10-27
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2004-10-27 / Terminated / root cause: labeling and UDI

FDA source

Abbott Health Products, Inc. began a recall of IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with... on 2004-10-27. The reason FDA records is "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". 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-0217-05
Status: Terminated
Initiated: 2004-10-27
Posted: 2004-11-20
Terminated: 2005-03-16
Recalling firm: Abbott Diagnostic International, Ltd.
Product: IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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).
Quantity in commerce: 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.A. Government accounts includes: VA Medical Center, Saint Louise, MO; Brecksville VA Hosp. Supp, Brecksville, OH; VA MED CENTER, Phoenix, AZ; Department Veterinary Affair Med., Houston, TX; VA Med., Cincinnati, OH; VA Med Center, Seattle, WA; Truman Mem. VA, Columbia, MO; Dept. Vet. Aff., Shreveport, LA; VA Hosp. Whse., Fresno, CA ; VA Med Center, Omaha, NE ; VA Med. Center, Lexington, KY; VA Med Center, Detroit, MI ; VA Hosp., San Diego, CA ; Naval Hosp., Great Lakes, IL; VA Med. Center, San Francisco, CA.
Product codes and lots: Lot # 18220Q100 Exp. March 02, 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)