AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
FDA device recall Z-0006-05 · posted 2004-10-05 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Assay may give elevated patients results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JHI
- Quantity affected
- 7830 kits
- Distribution
- Distribution was nationwide to laboratories and to the following government accounts: 375th MEDCL GRP, Scott AFB, IL, Logistic Div USA MEDDAC, Fort Drum, NY, MED MAT SVC SGSL, Colorado Springs, CO, Na
- Date initiated
- 2004-08-24
- Date posted
- 2004-10-05
- Date terminated
- 2005-07-21
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM TOTAL B-HCG (K935673) | Abbott Laboratories | 1994-06-21 |