Reported Jan 4, 2017 · Terminated
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack,…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ORTHO-CLINICAL DIAGNOSTICS · FELINDRE MEADOWS · Bridgend, N/A · N/A
Is this the product you have?
- VITROS Immunodiagnostic
- Products Intact PTH Reagent Pack1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) 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. Intact PTH is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively
- Lot codes and dates
- Lot / Expiry date
1) 0700 (18 Oct 2016)0710 (14 Nov 2016)0748 (16 Feb 20170758 (06 Mar 2017)2) 0728 (12 Dec 2016)0738 (02 Jan 2017)0768 (10 Apr 2017)
- Lot / Expiry date
- Amount recalled
- 7,027 Total units
Where it was sold
- Nationwide
Why it was recalled
The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation they discovered that the cleared reference interval (RI) was not set optimally at product launch in 2010 and that the upper limit in the IFU of 53.5pg/mL is too low and should be closer to 80 pg/mL. They are in the process of submitting the data to support the revised RI in a new 510K submission and will be changing the IFU once the 510K is cleared.
This product could cause temporary or reversible health problems — stop using it.
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