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QUANTA Flash® DGP IgA Calibrators

INOVA DIAGNOSTICS, INC. · Model 701166 · UDI-DI 08426950595083

JIX Prescription

510(k) clearances

582

Adverse events

Recalls

Facilities

Description

1. QUANTA Flash DGP IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

Recalls

Date	Firm	Reason
2026-07-01	Aniara Diagnostica LLC	Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin
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
2024-03-05	Randox Laboratories Ltd.	Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to o
2024-03-01	Randox Laboratories Ltd.	The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
2023-11-20	Randox Laboratories Ltd.	Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patie
2023-11-20	Randox Laboratories Ltd.	CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient
2023-11-13	Randox Laboratories Ltd.	There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and T
2023-10-26	Siemens Healthcare Diagnostics Inc	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due
2023-10-26	Siemens Healthcare Diagnostics Inc	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due
2023-10-26	Siemens Healthcare Diagnostics Inc	RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due

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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.