Z-0844-2019Class II

Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ...

Name: Z-0844-2019 Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ...
Creator: Ortho Clinical Diagnostics Inc
Published: 2018-11-29
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-11-29 / Terminated / root cause: manufacturing process

FDA source

Ortho Clinical Diagnostics Inc began a recall of Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic... on 2018-11-29. FDA classified it as Class II and gives the reason as "A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration". 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-0844-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-29
Posted: 2019-02-15
Terminated: 2024-02-06
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
Product code: JIS Calibrator, Primary
Reason for recall: A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On November 29, 2018, the firm sent a customer letter all affected customers. All consignees were notified of the issue and informed of revised instructions for VITROS Myoglobin Calibrators: - Reconstitute the calibrators using 1.0 mL distilled water, as per current instructions. - Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) - Discard reconstituted calibrators after 4 hours. - Acknowledge the information contained in this notification by completing and submitting the Confirmation of Receipt form no later than December 14, 2018. - Post this notification by each VITROS System at your facility that processes this assay or with the user documentation. - Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 4030
Distribution: Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and the Netherlands.
Product codes and lots: Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0844-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0844-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-27	2019-02-15

Product code JIS

K033300Class IIVitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersOrtho-Clinical Diagnostics, Inc. / cleared 2003-11-05

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)