FDA Recall
Terminated
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
Recall: Z-2586-2017
·
Initiated March 13, 2012
Recall
- Recall Number
- Z-2586-2017
- Event Number
- 77003
- Firm
- Medtest Holdings, Inc.
- FEI Number
- 1827821
- Product Code
- CIG
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 13, 2012
- Posted
- June 14, 2017
- Terminated
- July 24, 2017
- Address
- 5449 Research Dr, Canton, MI, 48188-2261
Description
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
Reason
Decrease reactivity of R 1 component.
Action
On 3/13/2012 and 5/3/2012, Field Correction Notice notifications were sent to the affected consignees via e-mail/fax. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.
Distribution
Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
Quantity
270.36 L