Health product recall

Liquidchek Urine Chemistry Control Niveau 2 (2018-05-11)

Starting date:
May 11, 2018
Posting date:
June 1, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66906

Affected products

Reason

Bio-Rad Laboratories (Canada) is initiating this recall after receiving multiple customer complaints indicating some analyte values in certain vials of Liquichek Urine Chemistry Contrai Level 2, Lot 68512, are recovering outside the package insert ranges with high CVs. This could potentially be indicative of microbial contamination in some vials. Due to this issue, we recommend that you immediately discontinue the use of Lot 68512.

Affected products

A. Liquidchek Urine Chemistry Control Niveau 2

Lot or serial number

68512

Model or catalog number

398

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES

B. Liquichek Urine Chemistry Control Minipak

Lot or serial number

68510

Model or catalog number

395X

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES