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