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Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL

QUANTIMETRIX CORPORATION · Model 1510-02 · UDI-DI 00896863002066

JJX

510(k) clearances

693

Adverse events

Recalls

271

Facilities

Description

The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.