Recall Z-0267-2020
Ortho-Clinical Diagnostics · initiated September 10, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Codes / lots: 401006613389 401006613500 401006613501 401006613608 401006613609 401006613648 401006613671 401006613712 401006613796 401006613843 401006613890 401006584017 401006614028 401006584103 401006584161 401006584214 401006584259 401006584230 401006644380 401006644436 401006644502 401006644529 401006644574 401006584374 401006644604 401006644649 401006644670 401006644705 401006644745 401006644800 401006644871 401006644893 401006644896 401006664973 401006665040 401006665041 401006665223 401006665225 401006665226 401006665248 401006665295 401006665227 401006665228 401006665229 401006665306 401006675376 401006675473 401006675474 401006675513 401006675514 401006675559 401006675477 401006675478 401006675501 401006675552 401006675553 401006675630 401006675631 401006675659 401006675660 401006675803 401006695852 401006695862 401006695908 401006695916 401006675801 401006675802 401006695945 401006676062 401006676063 401006696041 401006696057 401006696079 401006696093 401006767884 401006767998 401006767999 401006768049 401006767969 401006768082 401006767882 401006768133 401006767904 401006767905 401006768134 401006768149 401006768150 401006768183 401006778247 401006778277 401006778340 401006778357…
Reason for recall
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
FDA-determined cause: Process control
Action taken
On September 10, 2019, the firm distributed Urgent Product Correction Notification letters to affected customers. Customers were asked to take the following actions: "Complete and return the Confirmation of Receipt form. "If you experience a slide dispense issue, try to reposition the ABP by following the instructions in the enclosed Resolving Slide Dispense Issues document. Please place the instructions by each VITROS System in your facility that processes Microslides. "If you are unable to reposition the ABP, remove the affected cartridge and replace it with a new one. Complete and return the Request for Credit form as needed to receive credit for the slides remaining within affected and discarded cartridges. "Please forward this notification if the product was distributed outside of your facility. The firm will provide credit for the slides remaining within affected cartridge for which you are unable to reposition the ABP. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Details
- Recall number
- Z-0267-2020
- Initiated
- September 10, 2019
- Terminated
- November 13, 2020
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Quantity
- 1365545 total
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0268-2020 Class II | VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | 09/10/2019Terminated |
| Z-0269-2020 Class II | VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | 09/10/2019Terminated |