Abbott Health Products, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
Lot # 18220Q100 Exp. March 02, 2005
Products Sold
Lot # 18220Q100 Exp. March 02, 2005
Abbott Health Products, Inc. is recalling IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and due to Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IL, KY, LA, MI, MO, NE, OH, TX, VA, WA, PR
Page updated: Jan 10, 2026