Z-0247-2022Class III

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the...

Name: Z-0247-2022 VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2021-10-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-10-15 / Terminated

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic... on 2021-10-15. FDA classified it as Class III and gives the reason as "Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0247-2022
Classification: Class III
Status: Terminated
Initiated: 2021-10-15
Posted: 2021-11-17
Terminated: 2023-12-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
FDA root cause: Under Investigation by firm
Action: On October 15, 2021, the firm issued "Important Product Correction Notification" letters to affected customers. Customers were informed that up to 8 booklets in the affected lot contained the range of means information for VITROS Immunodiagnostic Products Anti-HBc Controls instead of the control values for VITROS Anti-HBc IgM. Customers were provided with a copy of the correct Controls Values booklet. Customers were asked to do the following: - Complete and return the included Confirmation of Receipt - Response Required customer response form by email to: [email protected] or fax to: 1-888-557-3759 or 1-585-453-4110 - Retain the included Controls Values booklet to use in place of any recalled booklets - Forward the notification if the product was distributed outside your facility If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 191 units
Distribution: US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.
Product codes and lots: Lot 1690 UDI 10758750001200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0247-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0247-2022	Class III	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-17

Product code JJX

K032993Class IVitros Immunodiagnostic Products Anti-Hbc Igm ControlsOrtho-Clinical Diagnostics, Inc. / cleared 2003-10-31

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)