FDA Device Recall Z-0002-2018: The Binding Site Group, Ltd.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2018.

Recall Res Number

Z-0002-2018

Recalling Firm / Manufacturer

The Binding Site Group, Ltd.

FEI Number

3002808340

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-08-23

Date Posted

N/A

Date Terminated

2019-02-21

Product Code

DEM

Event Number

78047

Product Quantity

361 kits

Product Description Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

Reason for Recall The high control for the kit is recovering low and may be out of range for assigned values.

Action Details Binding Site sent an Field Safety Notice dated August 24, 2017, explaining the reason for recall and requesting the direct account and their customer to remove the affected kits from inventory and dispose of them. The direct account and their customers were instructed to circulate the field safety notice to other persons who use the product within their organization. A response form, to be returned via email, was enclosed for completion to indicate the number of kits discarded. For further questions, please call (858) 453-9177.

Distribution Pattern Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.

Code Information / Serial Numbers Lot #400900, Exp. 12/31/2017, UDI #05051700016421

Related Establishments / Registrations

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER Registration: 1000403749 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
KAMIYA BIOMEDICAL COMPANY LLC Registration: 2084025 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
THE BINDING SITE Registration: 3012471076 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
KENT LABORATORIES, INC. Registration: 3019906 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
The Binding Site Group Ltd. Registration: 9614373 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

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Medical Device Recall: Z-0002-2018

Recall Parameters & Description

Related Establishments / Registrations

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