Control, Cell Counter, Normal And Abnormal
Hematology · 21 CFR 864.8625
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedJul 3, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Z-2087-2025 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedJul 3, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Z-2088-2025 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedJul 3, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Z-2089-2025 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Onechipdx Biotech (suzhou) Co., Ltd
Suzhou Jiangsu, CN
Streck Llc
La Vista, NE, US
Mark Enterprises
Nashik Maharashtra, IN
Abbott Laboratories
Lake Forest, IL, US
R & D Systems, Inc.
MINNEAPOLIS, MN, US
Bio-rad Laboratories Inc.
Irvine, CA, US
Bio-rad Laboratories Inc.
IRVINE, CA, US
Marken Healthtech Limited
NASHIK Maharashtra, IN
Sts Corporation
Duluth, GA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
510(k) clearances
12 clearances for this product code
- Streck Laboratories, Inc.Nov 30, 1999
K993825 · PARA TECH PLUS RETICS
- Bio-RadJun 16, 1994
K942209 · LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
- R&D Systems, Inc.Dec 6, 1993
K934497 · CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
- Streck Laboratories, Inc.May 28, 1991
K911582 · STAK-CHEX
- Unipath , Ltd.Aug 22, 1990
K902391 · CELL-DYN 3000 CONTROL
- Hematronix, Inc.Aug 22, 1990
K902389 · TRI-COUNT 16
- Streck Laboratories, Inc.May 30, 1990
K901875 · PARA 12 PLUS
- Streck Laboratories, Inc.Nov 9, 1989
K896154 · PARA TECH FOR TECHNICON H-1