VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Summary
The FDA issued a Class II for VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 by Ortho-Clinical Diagnostics, Inc. Reason: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low En.
Details
Source
Device Recall
External ID
Z-1112-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Lot/Code Info: Until further notice, future lots will also be affected. UDI: 10758750000302 Affected Lot Number/ Expiration Date: 3100 01-MAR-2022; 3111 25-MAR-2022; 3120 04-APR-2022; 3130 25-APR-2022; 3140 10-MAY-2022; 3145 10-MAY-2022; 3150 30-MAY-2022; 3160 09-JUN-2022; 3170 22-JUN-2022; 3180 02-AUG-2022; 3190 16-AUG-2022; 3200 06-SEP-2022; 3210 12-SEP-2022.
Quantity Affected: 2502 total: 2154 US; 348 OUS
Reason for Recall
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Distribution
Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-25
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 164 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-1112-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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