Abbott Health Products, Inc. AxSYM Total B-hCG Reagent Pack Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AxSYM Total B-hCG Reagent Pack
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
Lots numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
Products Sold
Lots numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
Abbott Health Products, Inc. is recalling AxSYM Total B-hCG Reagent Pack due to Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
Recommended Action
Per FDA guidance
Device recall letters dated 7/7/04 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 (U.S. 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