Ortho-Clinical Diagnostics: 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

Recall number

Z-0392-2019

Recalling firm

Ortho-Clinical Diagnostics

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

Status

Terminated

Initiated

2018-08-28

Posted

not on file

Terminated

2020-08-11

Reason

The reagent pack exhibits the potential for an increased frequency of calibration failures.

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: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM. " 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

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.

Lot, serial or model codes

Lot 2601, 2610, 2620

510(k) numbers

["K013899","K984321"]

PMA numbers

not on file

Product code

CDD

Firm FEI

1000136573

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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