VITROS recallZ-0471-2021 · Ortho Clinical Diagnostics Inc · initiated Oct 16, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Clinical Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
FDA root cause category: Under Investigation by firm
What the company is doing
Ortho Clinical Diagnostics issued letter IMPORTANT PRODUCT CORRECTION NOTIFICATION (CL2020-243) on 16 October 2020 via FedEx/US Priority Mail or ORTHO Plus e-Communications for delivery on October 19, 2020, stating reason for recall, health risk and action to take: If their laboratory used VITROS Performance Verifier II Lot Q7692 to verify performance of VITROS ALKP Slides and stores an inventory of unopened vials in the refrigerator: Discard any remaining refrigerated inventory of unopened VITROS Performance Verifier II Lot Q7692. If their laboratory does not store inventory of VITROS Performance Verifier II Lot Q7692 in the refrigerator or does not use Lot Q7692 to verify performance of VITROS ALKP Slides: No Action Is Required. To verify performance of VITROS ALKP Slides, use frozen (never refrigerated) inventory of VITROS Performance Verifier II Lot Q7692 or switch to another lot of VITROS Performance Verifier II. Ortho will replace or credit your account as indicated on your Confirmation of Receipt form Retain this notification as verification of the revised instructions. OUS notified by email on 09/14/20 to global affiliates for distribution to distributors and customers.
Recall details
- Recall number
- Z-0471-2021
- Status
- Open, Classified
- Initiated by the company
- Oct 16, 2020
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Quantity
- 10788 total: US 4680; OUS 6108
- Product code
- JJY
- FDA submissions
- K904768
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Product description
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
Code information (models, lots, serial numbers)
Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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