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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products FS Calibrator 1

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 Class 3 Device Recall VITROS Chemistry Products FS Calibrator 1see related information
Date Initiated by FirmJanuary 05, 2017
Create DateFebruary 09, 2017
Recall Status1 Terminated 3 on June 22, 2018
Recall NumberZ-1181-2017
Recall Event ID 76200
510(K)NumberK041799 
Product Classification Calibrator, secondary - Product Code JIT
ProductVITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents
Code Information Lot 91461, Expiry Date 2018-09-19; Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
1000 Lee Road
Rochester NY 14606
For Additional Information ContactMs. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
FDA Determined
Cause 2		Under Investigation by firm
ActionOrtho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2017-002) and ADD DRV 5911dated January 5, 2017, to all affected customers. The letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to install Assay Data Diskette, DRV 5911 or above on their VITROS System. Foreign affiliates were informed by e-mail on January 5, 2017, of the issue and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Ortho Care Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in CommerceUS: 160 kits, Foreign: 642 kits
DistributionWorldwide Distribution - US (Nationwide and, Puerto Rico) and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIT
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