ClearanceBrief
Recall Z-1157-04 ยท EXE Protector, Ostomy

Beckman Coulter Inc

Immage Antidioxyribonuclease B (DNB) reagent part no. 447480

DateJul 23, 2004 (initiated Jan 29, 2003)
StatusTerminated
ReasonThe 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 causeOther
Quantity238
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.