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NCMDR Recall
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Reference Number:
mdprc 111 06 11 000
Date submitted:
6/27/2011
Manufacturer:
Ortho-Clinical Diagnostics
Device Type:
VITROS Chemistry Products
Description:
VITROS Chemistry Products PHBR Slides (phenobarbital) from Coating 0053
Medical Device Identifier:
VITROS Chemistry Products PHBR Slides Lots Manufactured from Coating 0053 (Product Code 8221384). Lot No: 2532-0053-0144 , 2532-0053-0149 , 2532-0053-0217 , 2532-0053-0615 , 2532-0053-0616 , 2532-0053-1472 , 2532-0053-1488 , 2532-0053-1489 , 2532-0053-1490 , 2532-0053-4961 , 2532-0053-4984 , 2532-0053-4996 , 2532-0053-4997.
Reason of Field Safety Corrective Action:
Ortho Clinical Diagnostics (OCD) has received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides (phenobarbital) from Coating 0053. OCD investigation has confirmed that biased values for patient samples could be obtained that may or may not be detected by quality control fluids.
Remedy Action:
- Discontinue using and discard all remaining lots of VITROS PHBR Slides, Coating 0053. - Complete and return the attached Confirmation of Receipt form upon receipt of this notification. Once the Confirmation of Receipt form is received, we will begin the replacement order process. - Forward this notification to all departments that utilize the VITROS PHBR Slides
Athorized Representative/Importer/Distributor:
Samir Photographic Supplies Co. Ltd, Riyadh (01) 4614769
Report Source:
NCMDR
Source Ref. Number:
BCE146B8462E1
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Manufacturer letter.pdf
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