Ortho-Clinical VITROS Calibrator Kit 9 Recall for Wash Errors
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text describes a product correction for wash errors without reporting any injuries, illnesses, or deaths. Per the rubric, documentation or operational issues without reported harm are classified as Low severity.
Plain-English summary
Ortho-Clinical Diagnostics is conducting a product correction for VITROS Chemistry Products Calibrator Kit 9, Lot 0954, with an expiration date of 31-May-2016. The recall involves 2,443 kits distributed domestically and 1,548 kits distributed to foreign countries, including Australia, Brazil, Canada, and others.
The firm is conducting this product correction due to an increase in U90-382 or 6LU condition codes, which are identified as wash errors, when using the affected calibrator kit. The VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
Healthcare facilities and laboratories should stop using the affected product and contact Ortho-Clinical Diagnostics for further instructions regarding the product correction.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistr
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 0954
- exp. date 31-May-2016
Distribution
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