VITROS Immunodiagnostic Products LH Reagent Pack recall
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Why was VITROS Immunodiagnostic Products LH Reagent Pack recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Until further notice, future lots will also be affected. UDI: 10758750008902 Affected Lot Number/ Expiration Date: 1910 14-AUG-2022 1920 19-SEP-2022 1930 19-OCT-2022 1940 31-OCT-2022 1950 28-JAN-2023 1960 31-JAN-2023
- Product
- VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
- Recalling firm
- Ortho-Clinical Diagnostics, Inc
- Quantity
- 1575 units total: 1183 US; 392 OUS
- 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
- Recall date
- May 25, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)