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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products PHBR Slides

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  Class 2 Device Recall VITROS Chemistry Products PHBR Slides see related information
Date Initiated by Firm March 14, 2013
Date Posted April 19, 2013
Recall Status1 Terminated 3 on June 23, 2015
Recall Number Z-1152-2013
Recall Event ID 64707
510(K)Number K984288  
Product Classification Enzyme immunoassay, phenobarbital - Product Code DLZ
Product VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384.

For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Code Information All Lot Numbers containing: GEN 38, Coating No. 0060, Expiration Date Range 03/01/13 through 07/01/13; GEN 39, Coating No. 0062, Expiration Date Range 07/01/13 through 09/01/13; GEN 40, Coating No. 0063, Expiration Date Range 10/01/13 through 12/01/13; GEN 41, Coating No. 0064, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.]. 
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 3/14/13, URGENT PRODUCT CORRECTION NOTIFICATION letters (dated 3/14/13), Questions & Answers, and Response Forms were sent to consignees via FedEx courier or US Postal Service Priority Mail. Consignees were informed of the issue and advised to immediately discontinue using VITROS PHBR Slides. On 3/14/13, distributor letters were sent via US Postal Service Priority Mail to the distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS PHBR Slides. On 3/14/13, foreign affiliates were informed by e-mail of the issue and instructed to notify their consignees of the issue and actions.
Quantity in Commerce Domestic: 11,164 units, Foreign: 594 units
Distribution Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DLZ and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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