VITROS 5600 Integrated System recall
VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Why was VITROS 5600 Integrated System recalled?
Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
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?
Serial Numbers 56000118 through 56001583
- Product
- VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- USA: 775 units, Foreign: 800 units
- Distribution
- Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)