Devices

Device Recall Wako Autokit Lp(a) Calibrator

Model / Serial
Lot No.: DJ427, Exp 08-31-12
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
The product had been sold to 2 customers in the US.
Product Description
Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics || 1600 Bellwood Road Richmond, VA 23237*** || Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.
Manufacturer
Wako Chemicals USA, Inc.
1 Event
- Recall of Device Recall Wako Autokit Lp(a) Calibrator

Manufacturer

Wako Chemicals USA, Inc.

Manufacturer Address
Wako Chemicals USA, Inc., 1600 Bellwood Rd, Richmond VA 23237-1326
Manufacturer Parent Company (2017)
FUJIFILM Holdings Corp.
Source
USFDA

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