VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product C
Summary
The FDA issued a Class II for VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For by Ortho-Clinical Diagnostics, Inc.. Reason: Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VI.
Details
Source
Device Recall
External ID
Z-0220-2023
Action Date
2022-11-16
Status
Ongoing
Category
device
Product Description
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT
Lot/Code Info: UDI-DI: 10758750005031 Kit Lots/Exp. Date: 0911 24-MAY-2023; 0921 04-OCT-2023; 0942 06-JUN-2024; 0980 26-OCT-2022; 0991 01-MAR-2023 VITROS Chemistry Products PHYT Slides, GEN 22, All lots Calibration Diskette Data Release Versions (DRVs) 6194 through 6200 supporting VITROS Calibrator Kit 9.
Quantity Affected: 17,396 Units
Reason for Recall
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.
Distribution
Worldwide Distribution: US (Nationwide) and Countries (Foreign) including: Australia Bermuda DV04 Bermuda, HM 13 Bermuda, HM08 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-13
Company
Raritan, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, Inc. have FDA actions?
Ortho-Clinical Diagnostics, Inc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0220-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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