MZCClass I
System, Detection, Bacterial, For Platelet Transfusion Products
Microbiology · 21 CFR 866.2560
MDR events70All time
Recalls0All time
Registered firms23Currently listed
510(k) clearances0All time
Recent MDR events
70 adverse event reports on file
- BD BACTEC PLATELET AEROBIC/F MEDIUMMay 29, 2025MalfunctionBecton Dickinson & Co.MW5170871
- BD BACTEC PLATELET AEROBIC/F CULTURE VIALS (PLASTIC),40 MLMay 30, 2024InjuryBecton Dickinson Caribe Ltd.2647876-2024-00083
- BACT/ALERT BPA EU 100 BTLS - 279044Mar 7, 2024MalfunctionBiomérieux Inc.3002769706-2024-00006
- BACT/ALERT BPN EU 100 BTLS - 279045Mar 7, 2024MalfunctionBiomérieux Inc.3002769706-2024-00007
- BACT/ALERT BPN EU 100 BTLS - 279045Mar 7, 2024MalfunctionBiomérieux Inc.3002769706-2024-00008
- BACT/ALERT BPA EU 100 BTLS®Feb 20, 2024MalfunctionBiomerieux Inc.3002769706-2024-00002
- BACT/ALERT BPA EU - 279044Nov 3, 2023MalfunctionBiomérieux Inc.3002769706-2023-00023
- BACT/ALERT BPN USFeb 1, 2023MalfunctionBiomérieux, Inc3002769706-2023-00001
- BACT/ALERT® BPA EUNov 16, 2022MalfunctionBiomérieux, Inc3002769706-2022-00048
- BACT/ALERT BPNSep 24, 2022MalfunctionBiomérieux, Inc3002769706-2022-00044
Event type breakdown
Malfunction53
Injury12
Death3
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
23 firms currently registered for this product code
Becton, Dickinson & Co.
SPARKS, MD, US
Bbi Solutions Oem Limited
Crumlin Newport, GB
Gvs Tm, Inc.
Covina, CA, US
Sterigenics Us, Llc
Lewis Center, OH, US
Ups Supply Chain Solutions, Inc.
Mira Loma, CA, US
Ups Supply Chain Solutions, Inc.
Pedricktown, NJ, US
Becton Dickinson Caribe Ltd.
CAYEY, PR, US
Haemotronic De Mexico S De Rl
REYNOSA Tamaulipas, MX
Sterigenics U.s., Llc
Corona, CA, US
Biomerieux, Inc.
DURHAM, NC, US
Verax Biomedical Incorporated
Westborough, MA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.