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FDA Medical Device Recalls (openFDA)

Hamilton Co: Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.

Recall number
Z-1169-2007
Recalling firm
Hamilton Co
Product
Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.
Status
Terminated
Initiated
2007-03-29
Posted
2007-08-16
Terminated
2007-12-21
Reason
Some product containers may be leaking.
Root cause
Other
Action
The firm contacted consignees via certified mail and e-mail, initated on March 29, 2007.
Quantity
797 boxes
Distribution
Product was distributed to 3 US consignees in NJ, WA and TX, with one consignee in France.
Lot, serial or model codes
Part number 148482, lot codes 34906, 20207, 30307, 30407, 20507, 30607, 20707, 40707.
510(k) numbers
not on file
PMA numbers
not on file
Product code
JQW
Firm FEI
2915796
Firm city
Reno
Firm state
NV
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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