| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00495-1 |
| Product Name/Description |
Liquichek Urine Chemistry Control Level 2 and Liquichek Urine Chemistry Control MiniPak (contains Level 2). An in vitro diagnostic medical device (IVD)
Liquichek Urine Chemistry Control Level 2
Catalogue Number: 398
Lot Number: 68512
Expiry Date: 30 Sept 2019
Liquichek Urine Chemistry Control MiniPak (contains Level 2)
Catalogue Number: 395X
Lot Number: 68510
Expiry Date: 30 Sept 2019
ARTG Number: 206309
(Bio-Rad Laboratories - Clinical chemistry biological screening IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad have received multiple customer complaints indicating that some analyte values in certain vials of Liquichek Urine Chemistry Control Level 2, Lot 68512, are recovering outside the package insert stated ranges, namely high CVs.
The performance of Level 1, Lot 68511 is not impacted.
To date, there have been no reports of injury or illness as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Bio-Rad is advising customers to inspect and quarantine affected units to prevent further use. Customers are advised to discard any remaining inventory of Liquichek Urine Chemistry Control, Level 2 Lot 68512 and MiniPak 395X Lot 68510 (that contains the level 2).
Users are advised to contact Bio-Rad to make arrangements for replacement or to alter any pending orders or shipments. The replacement stock of Liquichek Urine Chemistry Control Level 2 is Lot 65822.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |