VITROS Immunodiagnostic Products TSH Reagent Pack…

Date

Aug. 24, 2016

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

Reason

A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.

Distribution pattern

Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada

Quantity

Domestic: 2883, Foreign: 1261

Codes and lots

Lot 5040 (Expiry date 19 Dec 2016)

Recall started

July 28, 2016

Device type

Radioimmunoassay, Thyroid-Stimulating Hormone

Root cause (FDA)

Under Investigation by firm

What the company told customers

Ortho Clinical Diagnostics sent an Important Product Correction Notification letter on July 28, 2016, via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS Immunodiagnostic Product TSH, Lot 5040 to inform them of the issue and the required actions. Instructions were provided to customers. Customers with questions were instructed to contact Ortho Care" Technical Solutions Center at 1-800-421-3311. Foreign affiliates were informed by e-mail on July 28, 2016, of the issue and instructed to notify their consignees of the issue and the required actions. For questions regarding this recall call 908-218-8776.

Recall number

Z-2580-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2580-2016. The agency record governs; check it and the company before acting.