Recall Z-2586-2017 ยท CIG Diazo Colorimetry, Bilirubin
Medtest Holdings, Inc.
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.
| Date | Jun 14, 2017 (initiated Mar 13, 2012) |
| Status | Terminated |
| Reason | Decrease reactivity of R 1 component. |
| Root cause | Nonconforming Material/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. |
| Quantity | 270.36 L |
| Distribution | Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040391 | TOTAL BILIRUBIN REAGENT SET Pointe Scientific, Inc.,, Jun 2, 2004 |