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FDA Medical Device Recalls (openFDA)

Beckman Coulter Inc: Immage Antidioxyribonuclease B (DNB) reagent part no. 447480

Recall number
Z-1157-04
Recalling firm
Beckman Coulter Inc
Product
Immage Antidioxyribonuclease B (DNB) reagent part no. 447480
Status
Terminated
Initiated
2003-01-29
Posted
2004-07-23
Terminated
2004-08-30
Reason
The expiration date encoded on the IMMAFE Antideoxyribonuclease B (DNB) reagent card for lot number M106152G is incorrect and should be replaced with the one sent having a 'G' which is printed after the lot number on the reagent bar code card. Cartridge expiration dates are correct.
Root cause
Other
Action
not on file
Quantity
238
Distribution
not on file
Lot, serial or model codes
Lot M106152 exp 2003-07-31
510(k) numbers
not on file
PMA numbers
not on file
Product code
EXEMP
Firm FEI
2050012
Firm city
Brea
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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