Recall Z-1436-04 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Abbott Health Products, Inc.
AxSYM Total B-hCG Reagent Pack
| Date | Sep 2, 2004 (initiated Jul 7, 2004) |
| Status | Terminated |
| Reason | Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations. |
| Root cause | Other |
| Action | 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. |
| Quantity | 5617 kits |
| Distribution | Distribution was nationwide to Laboratories and to the following government accounts: Logistic Div USAMEDAC Lab, Fort Drum, NY Keller Army Hospital Med Sup, West Point, NY VA MED CTR SUP SRV, Milwaukee, WI Weed Army Comm Hosp Lab, Fort Irwin, CA Shaw AFB 20th MDSS SGSL, Shaw AFB, SC Contr Officer, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935673 | AXSYM TOTAL B-HCG Abbott Laboratories, Jun 21, 1994 |