Recall Z-0912-2018
Ortho-Clinical Diagnostics · initiated September 22, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
Codes / lots: Catalog# 6802328 Lot# J5617
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.
FDA-determined cause: Under Investigation by firm
Action taken
On September 18, 2017 a letter was sent to customers who received the BENZ reagent within the past 18 months of affected lots. The letter stated that customers may continue use of the product if QC results using VITROS DAT Performance Verifiers are within established ranges for each assay. If QC BENZ results are below established ranges, the customer should discontinue use of the product. The letter requests customers post the notification by each system that processes the VITROS BENZ Reagent. If the product was transferred outside of the facility, to notify those customers as well. Affected lots will be replaced in 6-8 weeks. Questions or concerns can be directed to 585-453-3452
Details
- Recall number
- Z-0912-2018
- Initiated
- September 22, 2017
- Terminated
- August 24, 2020
- Product code
- DIF – Drug Mixture Control Materials
- Quantity
- 323
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0911-2018 Class II | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0913-2018 Class II | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0914-2018 Class II | VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0915-2018 Class II | VITROS Chemistry Products DAT Performance Verifier V in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |