Z-0392-2019Class II

VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic...

Name: Z-0392-2019 VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic...
Creator: Ortho-Clinical Diagnostics
Published: 2018-08-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-08-28 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of... on 2018-08-28. FDA classified it as Class II and gives the reason as "The reagent pack exhibits the potential for an increased frequency of calibration failures". 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-0392-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-28
Posted: 2018-11-06
Terminated: 2020-08-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia
Product code: CDD Radioassay, Vitamin B12
Reason for recall: The reagent pack exhibits the potential for an increased frequency of calibration failures.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm, Ortho Clinical Diagnostics, sent an "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated 8/28/18 to customers. A second "IMPORTANT UPDATE: PRODUCT CORRECTION NOTIFICATION" letter dated 10/22/18 was distributed to customers to inform them of additional affected lots. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: If this lot was successfully calibrated and your quality control results are acceptable; you may continue using your existing inventory of VITROS Vitamin B12 Reagent Pack 1/2 Lot 2601 until your replacement order arrives. We advise that you perform quality control on every reagent pack. " If this lot cannot be successfully calibrated, contact our Ortho Care" Technical Solutions Center. " Complete the Confirmation of Receipt Response Required form and return by September 12, 2018 (so that we can credit your account or expedite your replacement order) via Fax: to: 1.888.557.3759 or 1.585.453.4110 or e-Mail to: [email protected]. " Discontinue using Lot 2601 upon receipt of your replacement order. " Post this notification by each system that processes VITROS Vitamin B12 Reagent Pack 1/2. " Forward this notification if the product was distributed outside of your facility The distributors were instructed to do the following: Discontinue distributing and discard all inventory of VITROS Vitamin B12 Reagent Pack 1/2 and Calibrators for Lot 2610 and/or 2620. " Send the customer letter to all customers who were shipped VITROS Vitamin B12 Reagent, Lots 2610 and/or 2620 from your facility. " Complete and return the Confirmation of Receipt form no later than November 5, 2018. " Forward this notification if you have distributed this product outside of your facility. If you have further questions, please contact our Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 6630
Distribution: Worldwide Distribution: US (nationwide) to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of: Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and UK.
Product codes and lots: Lot 2601, 2610, 2620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0392-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0392-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-06

Product code CDD

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)