VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number

FDA device recall Z-1226-2014 · posted 2014-03-19 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

CIG

Quantity affected

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 Pana

Date initiated

2014-01-09

Date posted

2014-03-19

Date terminated

2015-07-07

Location

Rochester, NY

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