AxSYM Total B-hCG Reagent Pack
FDA device recall Z-1436-04 · posted 2004-09-02 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 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, Milwauke
- Date initiated
- 2004-07-07
- Date posted
- 2004-09-02
- Date terminated
- 2004-12-01
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM TOTAL B-HCG (K935673) | Abbott Laboratories | 1994-06-21 |