Devices

Device Recall PROT 1 CON H

Model / Serial
Lot numbers: 6EQH01, 6EQH01A, 6EQH01B, 6EQH01C (exp. date 2017-09-17); 6LQH01A, 6LQH01B, 6LQH01C (exp. date 2018-04-04). --- Lot # (UDI): 6EQH01 (008427680063576EQH0120170917), 6EQH01A (008427680063576EQH01A2017091), 6EQH01B(008427680063576EQH01B20170917), 6EQH01C(008427680063576EQH01C20170917), 6LQH01A (008427680063576LQH01A20180404), 6LQH01B (008427680063576LQH01B20180404), 6LQH01C (008427680063576LQH01C20180404).
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
Product Description
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall PROT 1 CON H

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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