VITROS Immunodiagnostic Products Vitamin B12 Reagent recall
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative…
Why was VITROS Immunodiagnostic Products Vitamin B12 Reagent recalled?
The reagent pack exhibits the potential for an increased frequency of calibration failures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 2601, 2610, 2620
- Product
- VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative…
- Recalling firm
- Ortho-Clinical Diagnostics
- 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.
- Recall date
- November 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)