| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2019-RN-00696-1 |
| Product Name/Description |
Immunohaematology control - IH-QC1. An in vitro diagnostic medical device (IVD)
Catalogue Number: 009321
ID Number: 08710
All Lot Numbers
ARTG 232955
(Bio-Rad Laboratories Pty Ltd - Immunohaematology calibrator/control IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/05/2019 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad Laboratories have been made aware that the anti-D (RH1) = 0.05 IU/ml contained in the IH-QC1 has given weaker reactions and sometimes negative results against D positive cells in 2 stage papain technique (set of cells ID-DiaCell IP-IIP-IIIP, ID-DiaPanel P and ID-DiaScreen VP-VIP).
The reaction level of the IH-QC1 is affected only for the control of Antibody Screening / Identification test methods performed in 2 stage papain technique in ID-Card "NaCl, Enzyme Test and Cold Agglutinins". (Id. n 50520). Weaker to negative results of IH-QC1 against D positive cells could result in invalidating the laboratory Quality Control for the 2 stage papain method and lead to a delayed reporting of the result.
All other applications of IH-QC1 including the detection of the anti-D = 0.05 IU/ml in Indirect Antiglobulin Testing (IAT) are performing according to specification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The 2 stage papain application is no longer recommended for IH-QC1, in the interim for the 2 stage papain we recommend the anti-c (anti-RH4) in IH-QC3, which shows good enhancement compared to untreated cells in IAT or alternatively to use the 2 stage papain in Coombs Card.
This action has been closed out on 31/10/2019 |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories or TechSupport.ANZCDG@bio-rad.com |