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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific Hitachi Total Bilirubin Rl Reagent

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 Class 2 Device Recall Pointe Scientific Hitachi Total Bilirubin Rl Reagentsee related information
Date Initiated by FirmMarch 13, 2012
Date PostedJune 14, 2017
Recall Status1 Terminated 3 on July 24, 2017
Recall NumberZ-2586-2017
Recall Event ID 77003
510(K)NumberK040391 
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
ProductPointe 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information ContactCustomer Support
800-445-9853
Manufacturer Reason
for Recall		Decrease reactivity of R 1 component.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce270.36 L
DistributionWorldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CIG
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