Z-0202-2016Class III

VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier...

Name: Z-0202-2016 VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier...
Creator: Ortho-Clinical Diagnostics
Published: 2015-09-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-09-28 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical... on 2015-09-28. FDA classified it as Class III and gives the reason as "The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954". 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-0202-2016
Classification: Class III
Status: Terminated
Initiated: 2015-09-28
Posted: 2015-11-02
Terminated: 2018-05-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
Product code: JIT Calibrator, Secondary
Reason for recall: The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Customer letter (Ref. CL2015-191) was sent on 9/28/2015 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot, discard the remaining inventory of the affected lot and recalibrate VITROS DGXN and PHYT Slides using Cal Kit 9 with an alternative lot of calibrator kit 9 upon availability. Distributor letter (Ref. DL2015-191) was sent on 9/28/2015 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. The foreign affiliates were notified via e-mail on 9/28/2015.
Quantity in commerce: Domestic: 2443 kits; Foreign: 1548 kits
Distribution: Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela
Product codes and lots: Lot 0954, exp. date 31-May-2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0202-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0202-2016	Class III	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-03

Product code JIT

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)