CLASS II Device recall · Reported 17 Oct 2018 · FDA Enforcement Report
Vitros 5600 Integrated System- (Refurbished) recalled
Ortho-Clinical Diagnostics is recalling Vitros 5600 Integrated System- (Refurbished), distributed nationwide in the US. The recall was initiated on 15 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0080-2019
- FDA event ID
- 80959
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2018
- FDA classified
- 5 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Aug 2018 | Recall initiated by company | |
| 5 Oct 2018 | Classified by FDA | +51 days |
| 17 Oct 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Questions about this recall
Is Vitros 5600 Integrated System- (Refurbished) recalled?
Yes. Ortho-Clinical Diagnostics recalled Vitros 5600 Integrated System- (Refurbished) on 15 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0080-2019.
Why was it recalled?
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Which lots are affected?
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
Where was it sold?
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho-Clinical Diagnostics
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|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
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