Abbott Health Products, Inc. AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04
Products Sold
Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04
Abbott Health Products, Inc. is recalling AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 due to Assay may give elevated patients results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Assay may give elevated patients results.
Recommended Action
Per FDA guidance
Device recall letters dated 8/24/2004 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (US only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.
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