Recall Z-2586-2017
Medtest Holdings, Inc. · initiated March 13, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.
Reason for recall
Decrease reactivity of R 1 component.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2586-2017
- Initiated
- March 13, 2012
- Posted by FDA
- June 14, 2017
- Terminated
- July 24, 2017
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- 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
- Recalling firm
- Medtest Holdings, Inc., Canton, MI