VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics is recalling VITROS chemistry Products K+ Slides (Catalog No. 8157596), which are MicroSlides containing reagents in a dry, multi-layered form. The recall affects approximately 1,365,545 units distributed nationwide in the United States and internationally 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 the United Kingdom. Users may experience intermittent slide dispense issues with some cartridges because the anti-backup platen is failing to advance inside the cartridge.
The recall involves specific lot codes listed in the recall record. However, the source document does not specify what remedy is available to affected consumers or what actions they should take regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
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. 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. Quantity: 1365545 total Lot/code info: 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 410210066947 410210066992 410210067044 410210067073 410210067109 410210067201 410210067205 410210067287 410210067304 410210107327 410210137302 410210107400 410210107489 410210107514 410210107551 410210107603 410210107673 410210107674 410210127698 410210127910 410210127985 410210127978 410210128212 41021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.