VITROS Chemistry Products-HCY Reagent recall
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Why was VITROS Chemistry Products-HCY Reagent recalled?
The firm is recalling the specific lot due to lower than expected results.
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 # 1529-17-2636, expiration date 12 June 2013
- Product
- VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 478 total (339- Domestic) (139- International)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
- Recall date
- June 26, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)