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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80959

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 15, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ortho-Clinical Diagnostics

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413

Z-0079-2019
Recall number
Z-0079-2019
Initiated
August 15, 2018
Classification
Class II
Status
Terminated
Quantity
U.S.= 1255 ex-U.S.= 1504

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Serial Numbers : J56000024 through J56003300

Distribution pattern

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

device · product 2 of 2

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

Z-0080-2019
Recall number
Z-0080-2019
Initiated
August 15, 2018
Classification
Class II
Status
Terminated
Quantity
U.S.= 66 ex-U.S.= 76

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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