| Date Initiated by Firm |
February 01, 2017 |
| Create Date |
March 24, 2017 |
| Recall Status1 |
Terminated 3 on June 29, 2018 |
| Recall Number |
Z-1471-2017 |
| Recall Event ID |
76438 |
| 510(K)Number |
K924488
|
| Product Classification |
Flame photometry, lithium - Product Code JIH
|
| Product |
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical Diagnostics, Inc. Rochester, NY 14626 --- Background:
The VITROS Li Slide is a multilayered, analytical element coated on a polyester support. During the coating process, thin layers of reagents are coated onto a polyester support layer to create a spreading layer and a chemical (reagent) layer. During the coating process rolls of materials are produced. These rolls are segmented into slits. There are several slits in each roll. Each slit is then cut into small chemistry chips that are positioned between plastic to create the final Microslide format. Eighteen (18) or sixty (60) slides are placed into each plastic cartridge for use. Each slide is a device. |
| Code Information |
REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01 |
Recalling Firm/
Manufacturer |
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
|
| For Additional Information Contact |
Ms. Jennifer Paine
908-218-8776
|
Manufacturer Reason
for Recall |
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
On 2/01/ 2017, URGENT PRODUCT CORRECTION NOTIFICATION letter (Ref. CL2017-036, dated 2/01/2017) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected VITROS Chemistry Products Li Slides to inform them of the issue and to request that they immediately discontinue use of this product. The correction is to the user level. Discuss any concerns regarding previously reported VITROS Li results obtained from the affected with their Laboratory's Medical Director to determine the appropriate course of action. Ortho will be shipping replacement product. ---Foreign affiliates were informed of the issue by e-mail on 2/01/2017 and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. For questions, please contact our Ortho Care(TM) Technical Solutions Center at 1-800-421-3311. |
| Quantity in Commerce |
US: 94 sales units; OUS: 136 sales units |
| Distribution |
US, Puerto Rico, Canada, EU, China, Brazil, Chile, and Dominican Republic. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = JIH and Original Applicant = EASTMAN KODAK COMPANY
|
