VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750

FDA device recall Z-0202-2016 · posted 2015-11-02 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.

Action taken

Customer letter (Ref. CL2015-191) was sent on 9/28/2015 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications 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 calibrator lot, discard the remaining inventory of the affected lot and recalibrate VITROS DGXN and PHYT Slides using Cal Kit 9 with an alternative lot of calibrator kit 9 upon availability. Distributor letter (Ref. DL2015-191) was sent on 9/28/2015 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. The foreign affiliates were notified via e-mail on 9/28/2015.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JIT

Quantity affected

Domestic: 2443 kits; Foreign: 1548 kits

Distribution

Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panam

Date initiated

2015-09-28

Date posted

2015-11-02

Date terminated

2018-05-22

Location

Rochester, NY

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