Recall Z-1377-04 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Abbott Laboratories Diagnostic Div
Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
| Date | Aug 17, 2004 (initiated Jul 27, 2004) |
| Status | Terminated |
| Reason | Precipitate formed in product. |
| Root cause | Other |
| Action | Firm sent recall letters requesting destruction of kits in the field on July 27, 2004. |
| Quantity | 758 |
| Distribution | Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981799 | CREA Abbott Laboratories, Jul 22, 1998 |