FDA Device Recalls

Recalls /

#33160

Product

Immage Antidioxyribonuclease B (DNB) reagent part no. 447480

FDA product code
EXEMP
Affected lot / code info
Lot M106152 exp 2003-07-31

Why it was recalled

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 (FDA determination)

Other

Recalling firm

Firm
Beckman Coulter Inc
Address
200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Timeline

Recall initiated
2003-01-29
Posted by FDA
2004-07-23
Terminated
2004-08-30
Status

Source: openFDA Device Recall endpoint. Recall record ID #33160. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.