FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
- Recall number
- Z-1226-2014
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
- Status
- Terminated
- Initiated
- 2014-01-09
- Posted
- 2014-03-19
- Terminated
- 2015-07-07
- Reason
- An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.
- Root cause
- Error in labeling
- Action
- Ortho Clinical Diagnostics sent an Urgent Distributor Product Correction Notification letter dated January 9, 2014, via FedEx overnight courier to all affected customers. The letter notified users of the issue and the correct 460 nm value. Foreign affitliates were notified on January 9, 2014 via e-mail. The letter advised users to inspect their current inventory of VITROS White Correction Slides to determine if Lot 9052-0045-6358 is present. If there is remaining inventory of VITROS White correction Slides, Lot 9052-0045-6358, the remaining inventory may be discarded or the user may continue to use the product with the updated 460nm value provided. If VITROS White Correction Slides, Lot 9052-0045-6358 have been previously used to perform the reflectometer correction factors adjustment , then this procedure should be repeated using the corrected 460 nm values or an alternate lot of VITROS White Correction Slides. Customers were instructed to complete and return the Confirmation of Receipt Form and identify all customers and any other branches who were shipped the affected lot from their facility and send a copy of the customer communication. Customers were also instructed to forward the information if they have distributed the affected product outside of their facility. Customers with questions were instructed to call Customer Technical Services. For questions regarding this recall call 908-218-8776.
- Quantity
- 64 units worldwide
- Distribution
- Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
- Lot, serial or model codes
- Lot 9052-0045-6358, expiry date 01 Aug 2015
- 510(k) numbers
- ["K840880","K922072"]
- PMA numbers
- not on file
- Product code
- CIG
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28