Z-1471-2017Class II

VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90...

Name: Z-1471-2017 VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90...
Creator: Ortho-Clinical Diagnostics
Published: 2017-02-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-02-01 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog... on 2017-02-01. FDA classified it as Class II and gives the reason as "Intermittent imprecision in results generated using two specific lots of VITROS Li Slides". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1471-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-01
Posted: 2017-03-24
Terminated: 2018-06-29
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JIH Flame Photometry, Lithium
Reason for recall: Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: REF/Product Code 1632660: Lot 3124-0108-6568, exp. 2018- 04-01; REF/Product Code 8318925: Lot 3124-0108-6569, exp. 2018- 05-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1471-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1471-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-15

Product code JIH

K924488Class IIKodak Ektachem Clinical Chemistry Slides (Li)Eastman Kodak Company / cleared 1993-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)