Z-1181-2017Class III

VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with...

Name: Z-1181-2017 VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with...
Creator: Ortho-Clinical Diagnostics
Published: 2017-01-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-01-05 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to... on 2017-01-05. FDA classified it as Class III and gives the reason as "The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904...". 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-1181-2017
Classification: Class III
Status: Terminated
Initiated: 2017-01-05
Posted: 2017-02-09
Terminated: 2018-06-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS/4600 Chemistry and integrated Systems. --- Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 --- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- Background: VITROS assays must be calibrated prior to use in order to be used to produce assay results. The Assay Data Disk (ADD) contains calibrator assigned values/ calculation data for multiple VITROS Calibrators and Lots. The Data Release Version (DRV) number identifies the version of the ADD. Each time the ADD is updated with new ata, the DRV number increments higher. The DRV with the highest number contains the most current data. The VITROS 4600 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System are the only VITROS Systems that run the assays that are associated with VITROS Chemistry Products FS Calibrator 1. VITROS FS Calibrator 1 is required to calibrate VITROS RF, dLDL, hsCRP, AMPH, BARB, BENZ, COCM, CP, ASO, THC, d%A1c assays. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, d%A1c, dLDL, hsCRP, PCP, RF and THC Reagents
Product code: JIT Calibrator, Secondary
Reason for recall: The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 5908, 5909, and 5910 are all affected by this issue.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter (Ref. CL2017-002) and ADD DRV 5911dated January 5, 2017, to all affected customers. The letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to install Assay Data Diskette, DRV 5911 or above on their VITROS System. Foreign affiliates were informed by e-mail on January 5, 2017, of the issue and instructed to notify their consignees of the issue and required actions. Customers with questions were instructed to contact Ortho Care Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in commerce: US: 160 kits, Foreign: 642 kits
Distribution: Worldwide Distribution - US (Nationwide and, Puerto Rico) and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, and Venezuela.
Product codes and lots: Lot 91461, Expiry Date 2018-09-19; Affected Assay Data Diskettes (ADD) Release Versions 5904 through 5910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1181-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1181-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-09

Product code JIT

K041799Class IIVitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FsOrtho-Clinical Diagnostics, Inc. / cleared 2004-08-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)