IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate
FDA device recall Z-0894-05 · posted 2005-06-16 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
- Action taken
- Abbot Health Products, Inc informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 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
- 793 kits
- Distribution
- US Goverment, Domestic and International distribution.
- Date initiated
- 2005-03-24
- Date posted
- 2005-06-16
- Date terminated
- 2005-09-29
- Location
- Barceloneta, PR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMX TOTAL B-HCG (K912535) | Abbott Laboratories | 1991-07-01 |