VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
FDA Recall #Z-0547-2024 — Class II — October 10, 2023
Product Description
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
Reason for Recall
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Recalling Firm
Ortho-Clinical Diagnostics, Inc. — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
216 units
Distribution
US Nationwide. Global Distribution.
Code Information
Product Code: 6844461, UDI-DI: 10758750031610; Serial Numbers: J76000050 J76000878 J76001555 J76000033 J76000976 J76000108 J76000905 J76001558 J76000036 J76000983 J76000144 J76000909 J76001559 J76000043 J76001001 J76000148 J76000922 J76001565 J76000045 J76001027 J76000192 J76000930 J76001570 J76000106 J76001035 J76000195 J76000968 J76001577 J76000118 J76001070 J76000199 J76001106 J76001581 J76000211 J76001074 J76000200 J76001171 J76001583 J76000253 J76001095 J76000206 J76001172 J76001589 J76000257 J76001111 J76000207 J76001206 J76001592 J76000265 J76001121 J76000208 J76001207 J76001595 J76000274 J76001130 J76000241 J76001218 J76001596 J76000276 J76001141 J76000298 J76001230 J76001597 J76000278 J76001142 J76000313 J76001231 J76001599 J76000280 J76001144 J76000317 J76001232 J76001600 J76000281 J76001152 J76000324 J76001235 J76001611 J76000284 J76001155 J76000333 J76001239 J76001616 J76000288 J76001159 J76000342 J76001260 J76001617 J76000289 J76001174 J76000352 J76001263 J76001620 J76000290 J76001183 J76000353 J76001274 J76001638 J76000292 J76001189 J76000420 J76001292 J76001639 J76000293 J76001272 J76000422 J76001293 J76001643 J76000318 J76001273 J76000456 J76001294 J76001644 J76000370 J76001285 J76000459 J76001331 J76001647 J76000436 J76001309 J76000460 J76001340 J76001648 J76000446 J76001314 J76000468 J76001351 J76001650 J76000447 J76001328 J76000495 J76001357 J76001652 J76000618 J76001368 J76000502 J76001370 J76001659 J76000620 J76001377 J76000524 J76001376 J76001660 J76000628 J76001378 J76000525 J76001383 J76001666 J76000760 J76001379 J76000561 J76001384 J76001667 J76000782 j76001396 J76000609 J76001385 J76001668 J76000807 J76001399 J76000709 J76001392 J76001669 J76000838 J76001407 J76000743 J76001404 J76001671 J76000845 J76001408 J76000747 J76001406 J76001674 J76000855 J76001452 J76000783 J76001516 J76001675 J76000856 J76001457 J76000790 J76001517 J76001678 J76000888 J76001484 J76000803 J76001518 J76001679 J76000898 J76001547 J76000805 J76001519 J76001687 J76000901 J76001562 J76000806 J76001520 J76001692 J76000973 J76001563 J76000817 J76001535 J76001700 J76000862 J76001540 J76001703 J76000866 J76001549 J76001705 J76000868 J76001552 J76001711 J76000871 J76001553 J76001714 J76000873
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.