—#167126

Product

VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915

FDA product code: JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K081543
Affected lot / code info: Serial Numbers: US: 56000718 56001062 56000458 56000824 56000315 56001235 56000786 56000747 56000339 56000559 56000308 56000727 56000741 56000792 56000750 56000825 56001012 56001641 56001131 56000818 56000327 56000661 56000255 56001021 56000533 56001111 56001689 56001152 56001141 56000756 56000585 56000427 56000261 56001570 56001535 56001139 56000317 56001184 56001530 56001558 56001334 56001437 56000883 56001445 56000186 56000308 56000315 56000327 56000339 56000458 56000559 56000718 56000727 56000741 56000747 56000750 56000786 56000792 56000824 56000825 56001062 56001235 56001635 56001641 56000568 56001153 OUS: Serial No 56000362 56000528 56000245 56000283 56000330 56000377 56000399 56000413 56000437 56000464 56000634 56000740 56000740 56000749 56000758 56000758 56000759 56000759 56000826 56001246 56001461 56001461 56000438 56000414 56000416 56000528 56000555 56000642 56000560 56000537 56000867 56000515 56001487 56000200 56000331 56000428 56000463 56000466 56000632 56000923 56000416 56000567 56001487 56000539 56000459 56000642 56000669 56001482 56000439 56000555 56000147 56000179 56000214 56000260 56000277 56000415 56000426 56000535 56000582 56000680 56000820 56000827 56000994 56001133 56001135 56001451 56001859 56000393 56001027 56000646 56001128 56000655 56000796 56001359 56001851 56000928

Why it was recalled

Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

Root cause (FDA determination)

Software design

Action the firm took

ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent 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 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain

Timeline

Recall initiated: 2018-08-15
Terminated: 2022-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.