Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.
Brand
Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila
Lot Codes / Batch Numbers
Lot # 76175Q100 exp. date 4/18/10, Lot # 79412Q100 exp. date 7/22/10, Lot # 82584Q100 exp. date 10/20/10.
Products Sold
Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10.
Abbott Diagnostics International, Ltd. Carr # 2 Km 58.0 Cruce Davila is recalling ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative d due to There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.
Recommended Action
Per FDA guidance
Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.
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 noticePage updated: Jan 10, 2026