Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
FDA device recall Z-1377-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Reason for recall
- Precipitate formed in product.
- Action taken
- Firm sent recall letters requesting destruction of kits in the field on July 27, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGX
- Quantity affected
- 758
- Distribution
- Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
- Date initiated
- 2004-07-27
- Date posted
- 2004-08-17
- Date terminated
- 2012-05-02
- Location
- South Pasadena, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CREA (K981799) | Abbott Laboratories | 1998-07-22 |