VITROS Chemistry Products Calibrator Kit 9 Calibrator recall
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical…
Why was VITROS Chemistry Products Calibrator Kit 9 Calibrator recalled?
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
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 0954, exp. date 31-May-2016
- Product
- VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- Domestic: 2443 kits; Foreign: 1548 kits
- Distribution
- Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela
- Recall date
- November 11, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)