—#99648

Product

ARCHITECT HAVAB-M Assay 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; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25

FDA product code: LOL — Hepatitis A Test (Antibody And Igm Antibody)
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K063329
Affected lot / code info: List 6L21-25, lot 93794HN00, expiration date 2011-09-15

Why it was recalled

The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Abbott Laboratories issued a Product Recall letters dated April 20, 2011 to all affected customers that received ARCHITECT HAVAB-M reagent, lot 93794HN00. The letters informed the accounts of the increased grayzone and/or reactive results and were instructed to discontinue use of the lot and destroy any remaining inventory of the lot according to laboratory procedures. If the account did not have an alternate lot of reagent, they were told to continue using the recalled lot until their lab receives the replacement lot, and to perform supplemental testing with another HAVAB-M method to confirm the results for all specimens that are grayzone or reactive. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. For further questions regarding this please contact Abbott at 1-877-422-688

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Nationwide Distribution including Puerto Rico

Timeline

Recall initiated: 2011-04-20
Posted by FDA: 2011-06-06
Terminated: 2012-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99648. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.