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Terminated

VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.

FDA Recall Z-0202-2016 · Posted 2015-11-02

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJIT
Date Initiated2015-09-28
Date Terminated2018-05-22
Product QuantityDomestic: 2443 kits; Foreign: 1548 kits

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.

Firm Action

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

Distribution Pattern

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 Panama, Singapore, Spain and Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc. · 2008-10-23K941142KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOINEastman Kodak Company · 1994-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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