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.
Reported: June 26, 2013 Initiated: April 1, 2013 #Z-1556-2013
Product Description
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.
Reason for Recall
The firm is recalling the specific lot due to lower than expected results.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ortho-Clinical Diagnostics. Units affected: 478 total (339- Domestic) (139- International).
Why was this product recalled? ▼
The firm is recalling the specific lot due to lower than expected results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 26, 2013. Severity: Moderate. Recall number: Z-1556-2013.
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