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FDA Medical Device Recalls (openFDA)

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

Recall number
Z-0355-04
Recalling firm
Abbott Laboratories Diagnostic Div
Product
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
Status
Terminated
Initiated
2003-12-22
Posted
2004-01-16
Terminated
2004-09-21
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.
Lot, serial or model codes
This is not a lot specific issue.
510(k) numbers
not on file
PMA numbers
not on file
Product code
JGJ
Firm FEI
2018433
Firm city
South Pasadena
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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