VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Reported: March 14, 2018 Initiated: September 22, 2017 #Z-0915-2018
Product Description
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Reason for Recall
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 102
- Distribution
- Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic. Recalled by Ortho-Clinical Diagnostics. Units affected: 102.
Why was this product recalled? ▼
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0915-2018.
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