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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 098 05 18 000
Date submitted:	5/22/2018

Manufacturer:	Bio Rad
Device Type:	Liquichek Urine Chemistry Control, Level 2
Description:	Reagents, Clinical Chemistry, Control, Urine
Medical Device Identifier:	Catalog Numbers 398 and 395X Lot Nos. 68512 (Level 2), 68510 (MiniPak)
Reason of Field Safety Corrective Action:	Some analyte values in certain vials of Liquichek Urine Chemistry Control Level 2, Lot 68512, are recovering outside the package insert ranges with high CVs. This could potentially be indicative of microbial contamination in some vials. Due to this issue we recommend that you immediately discontinue use of Lot 68512. The performance of Level 1, Lot 68511 is not impacted.
Remedy Action:	- Discard all remaining inventory of Liquichek Urine Chemistry Control Lot 68512 that you have at your location in accordance with the requirements of your local waste management authorities. - Please contact your local Bio-Rad Laboratories Representative to make arrangements for any credit requests or to alter any pending orders or shipments. - Have the appropriate laboratory personnel complete the enclosed acknowledgment form to document that you have received this notice and are aware of this product quality notification. Please send the completed form back to your local Bio-Rad Laboratories Representative.
Athorized Representative/Importer/Distributor:	Al-Jeel Medical & Trading Co. LTD
Report Source:	NCMDR
Source Ref. Number:	342CFC94051F5
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Bio-Rad.pdf

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