Recall Z-0355-04 ยท JGJ Photometric Method, Magnesium
Abbott Laboratories Diagnostic Div
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
| Date | Jan 16, 2004 (initiated Dec 22, 2003) |
| Status | Terminated |
| Reason | Complaints that instructions for use were not clear. |
| Root cause | Other |
| Action | Firm sent customer letters dated 12/22/2003 which included updated instructions for use. |
| Quantity | 215 |
| Distribution | Nationwide and to Mexico, Brazil, Sinagapore, Venezuela, Puerto Rico, Hong Kong, Colombia, Dominican Republic, Australia, Ecuador, Canada, New Zealand, Argentina, Germany, Bahamas, Grand Cayman, El Salvador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.