SARS CoV-2 Controls (SARS-CoV-2)
RANDOX LABORATORIES LIMITED · Model COV10460 · UDI-DI 05055273216936
Description
"SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Negative/Non-Reactive Control SARS-CoV-2 Negative/Non-Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Negative/Non-Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems. SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Positive/Reactive Control SARS-CoV-2 Positive/Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus). SARS-CoV-2 Positive/Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems."
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-05-08 | Ortho-Clinical Diagnostics, Inc. | The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the u |
| 2024-01-09 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 De |
| 2023-05-18 | Ortho-Clinical Diagnostics, Inc. | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2023-01-09 | Siemens Healthcare Diagnostics, Inc. | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| 2021-10-15 | Ortho-Clinical Diagnostics, Inc. | Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the inc |
| 2021-04-30 | Sentinel CH SpA | Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users. |
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