Medical Device Recall: Z-0007-2015

FDA Recalls dataset · Firm: Ortho-Clinical Diagnostics · Status: Terminated

Recall Action Class: N/A Date Initiated: 2014-08-20 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2015.

Recall Res Number
Z-0007-2015
Recalling Firm / Manufacturer
Ortho-Clinical Diagnostics
FEI Number
1000305840
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2014-08-20
Date Posted
2014-10-02
Date Terminated
2017-04-11
Product Code
DIP
Event Number
69094
Product Quantity
Domestic: 339 sales units; Foreign: 10 sales units
Product Description VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for Recall Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some positively biased results were identified during testing of a different VITROS PHYT Slide lot; the affected slides were not released for distribution. Since Lot 2613-0150-4913 was manufactured in the same event, there is the potential for slides from this lot to also be affected.
Action Details On 8/20/14, an URGENT PRODUCT CORRECTION NOTIFICATION Letter (CL2014-222, dated 8/20/14) was sent via FedEx overnight courier and/or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. One foreign affiliate was notified on 8/20/14. One distributor was notified on 8/20/14. The customers were advised to: - Immediately discontinue using and discard VITROS Chemistry Products PHYT slide Lot 2613-0150-4913. Review VITROS PHYT results obtained using Lot 2613-0150-4913 and discuss any concerns they may have regarding previously reported results with their Laboratory Medical Director or with the requesting physician. Complete the attached Confirmation of Receipt form no later than 8/28/14. Forward the information in this notification if they have distributed this product outside of their facility facility.
Distribution Pattern Distributed USA (nationwide) and in Singapore.
Code Information / Serial Numbers Lot Number 2613-0150-4913, exp. 15-Nov-2014

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.