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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 015 01 13 000 |
| Date submitted: |
1/5/2013 |
| Manufacturer: | Abbott Diagnostic International Ltd |
| Device Type: | Reagent Controls and Calibrators, ARCHITECT |
| Description: | Reagent Controls and Calibrators |
| Medical Device Identifier: |
List Number:
(1) 7K73-20
(2) 7K73-25
(3) 7K73-01
(4) 7K73-10
Serial/Lot Number
(1) 11907JN01, 13909JN01, 15909JN01, 15916JN00,
18907JN01, 18907JN02, 21901JN01
(2) 11907JN00, 13909JN00, 15909JN00, 15916JN01,
18907JN00, 21901JN00, 21901JN03, 21901JN04
(3) 17342JN00, 19142JN00, 19142JN01, 19142JN02,
22270JN00, 23277JN00, 23277JN01
(4) 17203JN00, 19075JN00, 22121JN00, 23199JN00
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| Reason of Field Safety Corrective Action: |
The purpose of this letter is to communicate a field correction regarding the product labeling for safety precautions associated with the ARCHITECT Testosterone assay.
The current labels and package inserts for the ARCHITECT Testosterone Reagent, LN 7K73- 20 and 7K73-25, ARCHITECT Testosterone Calibrators, LN 7K73-01 and ARCHITECT Testosterone Controls, LN 7K73-10 do not contain the warnings and precautions applicable to material containing methylisothiazolones which are classified as skin sensitizers.
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| Remedy Action: |
Treat this product as a ‘skin sensitizer’. The following hazard symbol (See attached) applies to all ARCHITECT Testosterone product labeling.
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| Athorized Representative/Importer/Distributor: | Medical supplies & Services Co.Ltd Mediserv, Riyadh, (01) 4780555 |
| Report Source: | NCMDR |
| Source Ref. Number: | EEA5FD6BA83A3 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Abbott Diagnostic International Ltd.pdf |
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