Reported May 6, 2015 · Terminated
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number…
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
10758750001132 | and VITROS 5,1 FS Chemistry System |
6801890 | Refurbished, , Global Trade |
10758750001644 | IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents. |
- Lot codes and dates
- Software Version 2.8 & Below; VITROS 5,1 FS Chemistry System Serial Numbers 34000119 - 34002323; VITROS 5,1
- RefurbishedSerial
- Numbers - Domestic S/Ns
66 of 66 codes
340001333400019334000197340002123400028534000316340003183400033734000360340004203400045134000464340004783400049534000497340005293400053834000552340005573400059034000596340006013400063134000642340007613400079934000805340008333400085134000893340009463400094734001006340011723400121834001240340012433400124834001251340012743400129734001311340013173400134534001378340013793400138934001390340013963400142234001472340015043400156934001572340015893400161034001612340016263400163334001668
- Foreign S/Ns
152 of 152 codes
340001233400014334000191340002153400021934000235340002513400025634000260340002613400031934000331340003803400038234000406340004083400041234000426340004313400045434000464340004733400050134000523340005303400054134000542340005463400054834000553340005583400057634000577340005843400058534000609340006123400061534000616340006173400061834000620340006253400063734000644340006723400074434000745340007553400075934000776340007933400080034000814340008313400084434000846340008523400085634000870
- PLEASE NOTEThe serial numbers are sequential, but not all analyzers are released for distribution. Therefore, the amount of each system manufactured may not equal the amount of each system distributed
- Amount recalled
- VITROS 5.1 System: Domestic - 909; Foreign - 1250; 5,1 Refurbished: Domestic - 66 units, Foreign - 152
Where it was sold
Why it was recalled
Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ortho-Clinical Diagnostics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.