Recall Z-0269-2020
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 K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Codes / lots: 410209876551 410209876548 410209876539 410209950186 410209950196 410209950232 410209960354 410209960373 410209960330 410209960477 410209960495 410209970685 410209970716 410209970763 410209960548 410209960590 410209960591 410209960625 410209960626 410209970818 410209971322 410209971446 410209971447 410209971483 410209971484 410209971485 410209971602 410209971699 410209981652 410209981767 410209991938 410209991939 410210003291 410210003396 410210003507 410210003510 410210023496 410210023498 410210003645 410210003669 410210003719 410210003775 410210013798 410210013912 410210013938 410210013966 410210013996 410210014061 410210014053 410210024095 410210014134 410210024167 410210024196 410210024284 410210024342 410210024403 410210024438 410210024469 410210024506 410210044598 410210054742 410210044699 410210044700 410210044751 410210044842 410210045037 410210045051 410210045095 410210045097 410210045186 410210055198 410210055249 410210055278 410210085927 410210085928 410210085986 410210086101 410210086109 410210086142 410210086198 410210086287 410210086304 410210096368 410210096494 410210096478 410210096588 410210096658 410210096686 410210096701 410210096723 410210066822 410210066936…
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-0269-2020
- Initiated
- September 10, 2019
- Terminated
- November 13, 2020
- Product code
- CEM – Electrode, Ion Specific, Potassium
- 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-0267-2020 Class II | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-).…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | 09/10/2019Terminated |
| 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 |